CUTANIOUS GAS MONITOR
FDA premarket approval P830008/S001 · decided 1984-10-29
Approval details
- PMA number
- P830008
- Supplement
- S001
- Trade name
- CUTANIOUS GAS MONITOR
- Generic name
- MONITOR, CARBON-DIOXIDE, CUTANEOUS
- Applicant
- Sensor Medics Corp.
- Date received
- 1984-02-16
- Decision date
- 1984-10-29
- Days to decision
- 256 days
- Decision code
- APPR
- Product code
- LKD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Anaheim, CA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HIOX80 AEROSOL ADAPTER (K032516) | Sensor Medics Corp. | 2004-03-04 |
| INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION (K031745) | Sensor Medics Corp. | 2004-02-13 |
| LYRA NASAL MASK (K031883) | Sensor Medics Corp. | 2003-08-25 |
| MODIFICATION TO HIOX (K030943) | Sensor Medics Corp. | 2003-04-22 |
| PEGASUS NASAL CPAP SYSTEM (K022192) | Sensor Medics Corp. | 2003-01-24 |
| HI-OX (K020665) | Sensor Medics Corp. | 2002-07-30 |
| SOMNO STAR & SERIES SLEEP SYSTEM (K012085) | Sensor Medics Corp. | 2001-08-02 |
| MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT (K012034) | Sensor Medics Corp. | 2001-07-24 |