Novametrix Medical Systems, Inc.
Wallingford, CT, US
Novametrix Medical Systems, Inc. appears in FDA device records in Wallingford, CT. FDA records list 45 510(k) clearances between and , 13 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 45
- PMA records
- 13
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 45 510(k) clearances for Novametrix Medical Systems, Inc. between 1978 and 2001. The busiest year on record is 1987, with 6. The most recent is 2001, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 2 |
| 1979 | 4 |
| 1980 | 3 |
| 1981 | 3 |
| 1982 | 3 |
| 1983 | 1 |
| 1984 | 5 |
| 1985 | 4 |
| 1987 | 6 |
| 1989 | 2 |
| 1991 | 2 |
| 1992 | 1 |
| 1993 | 1 |
| 1996 | 2 |
| 1997 | 2 |
| 1998 | 1 |
| 2000 | 2 |
| 2001 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K010451 | NOVAMETRIX MARQUETTE COMPATIBLE SENSORS | DQA | Substantially Equivalent | |
| K000794 | MODIFICATION TO MARSPO2, MODEL 2001 | DQA | Substantially Equivalent | |
| K993979 | MARSPO2, MODEL 2001 | DQA | Substantially Equivalent | |
| K982499 | COSMO PLUS WITH NICO, MODEL 8200 | BZC | Substantially Equivalent | |
| K964360 | VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101 | BZC | Substantially Equivalent | |
| K963380 | CO 2 SMO PLUS | BZC | Substantially Equivalent | |
| K963327 | TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610 | CCK | Substantially Equivalent | |
| K960831 | VENTRAK RMMS 1550 | BZC | Substantially Equivalent | |
| K924626 | NOVAMETRIX MODEL 510 | DQA | Substantially Equivalent | |
| K920379 | NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX | DQA | Substantially Equivalent | |
| K913516 | MODEL 520A NOVAMETRIX PULSE OXIMETER | DQA | Substantially Equivalent | |
| K910019 | NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON | CCK | Substantially Equivalent | |
| K893643 | NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER | DQA | Substantially Equivalent | |
| K890517 | TRANSCUTANEOUS O2/CO2 MONITOR | LKD | Substantially Equivalent | |
| K873672 | MODEL 1010 PHYSIOLOGICAL SIGNAL TELEMETRY MONITOR | DRG | Substantially Equivalent | |
| K874036 | MODEL 7000 COMBINATION END TIDAL & PULSE OXIMETRY | CCK | Substantially Equivalent | |
| K873149 | NOVAMETRIX END TIDAL CO2 MONITOR, MODEL 1260 | CCK | Substantially Equivalent | |
| K873078 | NOVAMETRIX MODEL 505 PULSE OXIMETER | DQA | Substantially Equivalent | |
| K871338 | NOVAMETRIX MODEL 200 MAGSTIM | GWF | Substantially Equivalent | |
| K870805 | MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR | KLK | Substantially Equivalent | |
| K853124 | NOVAMETRIX PULSE OXIMETER, MODEL 500 | JOM | Substantially Equivalent | |
| K850487 | NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER | DSF | Substantially Equivalent | |
| K844010 | CPNOGARD CAPNOMETER 1250 | CCK | Substantially Equivalent | |
| K844253 | NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2 | KLK | Substantially Equivalent | |
| K844079 | NOVAMETRIX 860 PROTA. TRANSCUTANEOUS OXYGEN | KLK | Substantially Equivalent | |
| K842374 | NOVAMETRIX 850 TRANSCUTANEOUS OXYGEN | KLK | Substantially Equivalent | |
| K840993 | TRANSCUTANEOUS 800-OXYGEN MONITORS/801 | KLK | Substantially Equivalent | |
| K840560 | NEONATAL PHYSIOLOGICAL MONITOR 903 | DRT | Substantially Equivalent | |
| K840392 | NOVOX OXYGEN ANALYZER 400 | CCL | Substantially Equivalent | |
| K831578 | PHYSIOLOGICAL MONITOR #902 | DRT | Substantially Equivalent | |
| K821720 | PHYSIOLOGICAL DISPLAY SYSTEM, MODEL 1000 | DRT | Substantially Equivalent | |
| K813350 | NOVAMETRIX MODEL 807 TRANSCUT. MONITOR | KLK | Substantially Equivalent | |
| K813352 | NOVAMETRIX MODEL 816A TRANSCUT. OXYGEN | KLK | Substantially Equivalent | |
| K813351 | NOVAMETRIX NAVAGRAPH MODEL 312 RECORDER | KLK | Substantially Equivalent | |
| K811893 | NOVAMETRIX PHYSIOLOGICAL MONITOR #910 | DRT | Substantially Equivalent | |
| K811453 | NOVATRACER RECORDER | DSF | Substantially Equivalent | |
| K802955 | MONITOR, AIRWAY PRESSURE | CAP | Substantially Equivalent | |
| K800988 | NOVAMETRIX TCOMETTE #809 TRANS. MONITOR | KLK | Substantially Equivalent | |
| K792722 | NOVAMETRIX CPAP NASAL CANNULA | BZD | Substantially Equivalent | |
| K792011 | TC02M PRECISION GAS CALIBRATOR | KLK | Substantially Equivalent | |
| K792010 | TC02M ELECTRODE ADHESIVE RINGS | KLK | Substantially Equivalent | |
| K792009 | TC02 M OXYGEN ELECTRODE CONTACT | KLK | Substantially Equivalent | |
| K791152 | TCO2M MODEL 818 | KLK | Substantially Equivalent | |
| K781713 | ADAPTER, C/D SUCTION | BTR | Substantially Equivalent | |
| K781714 | PNEUMOGARD MODEL 1230 | CAP | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- BZCCalculator, Pulmonary Function Data
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- LKDMonitor, Carbon-Dioxide, Cutaneous
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
- DQAOximeter
- JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic
- DSFRecorder, Paper Chart
- GWFStimulator, Electrical, Evoked Response
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
- BTRTube, Tracheal (W/Wo Connector)
- BZDVentilator, Non-Continuous (Respirator)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Novametrix Medical Systems, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Novametrix Medical Systems, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain