Sensor Medics Corp.
Yorba Linda, CA, US
Sensor Medics Corp. appears in FDA device records in Yorba Linda, CA. FDA records list 26 510(k) clearances between and , 3 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
- 26
- PMA records
- 3
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 26 510(k) clearances for Sensor Medics Corp. between 1984 and 2004. The busiest year on record is 1992, with 7. The most recent is 2004, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1986 | 1 |
| 1992 | 7 |
| 1993 | 4 |
| 1994 | 1 |
| 1998 | 2 |
| 1999 | 2 |
| 2001 | 2 |
| 2002 | 1 |
| 2003 | 3 |
| 2004 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K032516 | HIOX80 AEROSOL ADAPTER | CAF | Substantially Equivalent | |
| K031745 | INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION | BZD | Substantially Equivalent | |
| K031883 | LYRA NASAL MASK | BZD | Substantially Equivalent | |
| K030943 | MODIFICATION TO HIOX | CBP | Substantially Equivalent | |
| K022192 | PEGASUS NASAL CPAP SYSTEM | BZD | Substantially Equivalent | |
| K020665 | HI-OX | CBP | Substantially Equivalent | |
| K012085 | SOMNO STAR & SERIES SLEEP SYSTEM | OLV | Substantially Equivalent | |
| K012034 | MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT | BZD | Substantially Equivalent | |
| K991972 | INFANT FLOW SYSTEM | BZD | Substantially Equivalent | |
| K984254 | INFANT FLOW NCPAP MASKS | BZD | Substantially Equivalent | |
| K981366 | STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES | BTY | Substantially Equivalent | |
| K974303 | INFANT FLOW SYSTEM | BZD | Substantially Equivalent | |
| K942211 | VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS | BTY | Substantially Equivalent | |
| K934272 | SENSORMEDICS MICROGARD MICROBIAL FILTER | CAH | Substantially Equivalent | |
| K923988 | SENSORMEDICS MODEL 2200 PULMONARY FUNCTION LABS | BZG | Substantially Equivalent | |
| K923989 | SENSORMEDICS MODEL 6200 AUTOBOX DL | BZG | Substantially Equivalent | |
| K925542 | OXYSHUTTLE II ,MODIFICATION | DQA | Substantially Equivalent | |
| K915833 | SENSORMEDICS MODEL 2600 PEDIATRIC PULMOONARY CART | BZC | Substantially Equivalent | |
| K915686 | MODEL 2900 METABOLIC MEASUREMENT CART | BZC | Substantially Equivalent | |
| K915848 | SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB. | DZJ | Substantially Equivalent | |
| K920111 | SENSORMEDICS MODEL 2130 SPIEOMETRY SYSTEM | BZG | Substantially Equivalent | |
| K915856 | SENSORMEDICS 4000 SERIES SLEEP SYSTEM | OLZ | Substantially Equivalent | |
| K920246 | SENSORMEDICS MODEL 922 SPIROMETER | BZG | Substantially Equivalent | |
| K913790 | SENSORMEDICS OXYSHUTTLE II(TM) | DQA | Substantially Equivalent | |
| K862617 | SENSORMEDICS OXYSHUTTLE(TM) | DQA | Substantially Equivalent | |
| K842041 | PULMONARY FUNCTION SYSTEM | BZG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph
- BTYCalculator, Predicted Values, Pulmonary Function
- BZCCalculator, Pulmonary Function Data
- DZJDriver, Wire, And Bone Drill, Manual
- CAHFilter, Bacterial, Breathing-Circuit
- LKDMonitor, Carbon-Dioxide, Cutaneous
- CAFNebulizer (Direct Patient Interface)
- DQAOximeter
- BZGSpirometer, Diagnostic
- OLVStandard Polysomnograph With Electroencephalograph
- CBPValve, Non-Rebreathing
- 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.
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Data as of , FDA export datePage updated Source: openFDA, public domain