Intertech Resources, Inc.
Fort Myers, FL, US
Intertech Resources, Inc. appears in FDA device records in Fort Myers, FL. FDA records list 29 510(k) clearances between and , no 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
- 29
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 29 510(k) clearances for Intertech Resources, Inc. between 1987 and 1996. The busiest year on record is 1988, with 6. The most recent is 1996, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 2 |
| 1988 | 6 |
| 1989 | 1 |
| 1990 | 4 |
| 1991 | 5 |
| 1992 | 2 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 5 |
| 1996 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K961318 | 1ST RESPONSE DISPOSABLE MANOMETER | CAP | Substantially Equivalent | |
| K955008 | HEAT & MOISTURE EXCHANGER | BYD | Substantially Equivalent | |
| K953580 | HEAT MOISTURE EXCHANGER | BYD | Substantially Equivalent | |
| K952223 | XENON GAS BREATHING CIRCUIT | IYT | Substantially Equivalent | |
| K952214 | SIMS INTERTECH HYPERINFLATION BAG SYSTEM | NHK | Substantially Equivalent | |
| K952169 | SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC | BTM | Substantially Equivalent | |
| K952062 | PFT FILTER | CAH | Substantially Equivalent | |
| K935036 | HEPA FILTERED HEAT AND MOISTURE EXCHANGER | BYD | Unknown | |
| K930816 | HEPA FILTERED HME | CAH | Substantially Equivalent | |
| K922479 | DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED | BZO | Substantially Equivalent | |
| K921624 | DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS | BYH | Substantially Equivalent | |
| K912504 | DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED | CAI | Substantially Equivalent | |
| K912065 | DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED | CAI | Substantially Equivalent | |
| K911328 | UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION | BZO | Substantially Equivalent | |
| K911298 | PRESSURE LIMITING ELBOW WITH MANOMETER PORT | BTM | Substantially Equivalent | |
| K910509 | PATIENT GAS SAMPLING LINE FOR OHMEDA 6000 | CCK | Substantially Equivalent | |
| K903519 | INTERTECH(TM) HEAT AND MOISTURE EXCHANGER | BYD | Substantially Equivalent | |
| K902733 | 1ST RESPONSE (TM) INFANT MANUAL RESUSCITATOR | BTM | Substantially Equivalent | |
| K900577 | 1ST RESPONSE REUSABLE MANUAL RESUSCITATOR (ADULT) | BTM | Substantially Equivalent | |
| K896923 | INTERTECH/INSPIRON (R) MEDICATION NEBULIZER KIT | CAF | Substantially Equivalent for Some Indications | |
| K894612 | INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM | NHK | Substantially Equivalent | |
| K883693 | RESUSCITATION BAG EXHALATION FILTER | CAH | Substantially Equivalent | |
| K882582 | STERILE INHALATION WATER TRANSFER SET | BTT | Substantially Equivalent | |
| K882739 | INTERTECH LARGE VOLUME WATER TRAP (LVW) | BYH | Substantially Equivalent | |
| K881231 | DABC NONCONDUCTIVE HEATED ANESTH. BREATH. CIRCUIT | BZE | Substantially Equivalent | |
| K881230 | FLEX TUBE | BZA | Substantially Equivalent | |
| K880304 | INSPIRON NEBULO BASIC EXTERNAL HEATER | CAF | Substantially Equivalent | |
| K871407 | MECONIUM ASPIRATOR | BSY | Substantially Equivalent | |
| K870253 | INSPIRON(R) BREATH FOR LIFE EMERG. RESUSCITATOR | CBP | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- BSYCatheters, Suction, Tracheobronchial
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- BYDCondenser, Heat And Moisture (Artificial Nose)
- BZAConnector, Airway (Extension)
- BYHDrain, Tee (Water Trap)
- CAHFilter, Bacterial, Breathing-Circuit
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- CAFNebulizer (Direct Patient Interface)
- NHKResuscitator, Manual, Non Self-Inflating
- BZOSet, Tubing And Support, Ventilator (W Harness)
- IYTSystem, Rebreathing, Radionuclide
- CBPValve, Non-Rebreathing
- BTMVentilator, Emergency, Manual (Resuscitator)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain