TCO2M MODEL 818 MONITOR
FDA premarket approval P810022/S013 · decided 1987-01-29
Approval details
- PMA number
- P810022
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TCO2M MODEL 818 MONITOR
- Generic name
- MONITOR, CARBON-DIOXIDE, CUTANEOUS
- Applicant
- Novametrix Medical Systems, Inc.
- Date received
- 1986-11-03
- Decision date
- 1987-01-29
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- LKD
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Wallingford, CT
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| NOVAMETRIX MARQUETTE COMPATIBLE SENSORS (K010451) | Novametrix Medical Systems, Inc. | 2001-04-25 |
| MODIFICATION TO MARSPO2, MODEL 2001 (K000794) | Novametrix Medical Systems, Inc. | 2000-04-10 |
| MARSPO2, MODEL 2001 (K993979) | Novametrix Medical Systems, Inc. | 2000-02-22 |
| COSMO PLUS WITH NICO, MODEL 8200 (K982499) | Novametrix Medical Systems, Inc. | 1998-10-16 |
| VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101 (K964360) | Novametrix Medical Systems, Inc. | 1997-04-04 |
| CO 2 SMO PLUS (K963380) | Novametrix Medical Systems, Inc. | 1997-01-22 |
| TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610 (K963327) | Novametrix Medical Systems, Inc. | 1996-11-20 |
| VENTRAK RMMS 1550 (K960831) | Novametrix Medical Systems, Inc. | 1996-05-29 |