CO 2 SMO PLUS
FDA 510(k) clearance K963380 · decided 1997-01-22
Clearance details
- K-number
- K963380
- Device name
- CO 2 SMO PLUS
- Applicant
- Novametrix Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-08-27
- Decision date
- 1997-01-22
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- BZC
- Device class
- 2
- Regulation number
- 868.1880
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Wallingford, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Resp Profile Monitor, 8100 Cosmo+, Respironics/Philips product. Used to provide spirometri recall (Z-1274-2010) | Philips Healthcare Inc. | 2010-04-08 |
| Spanish 100-120V Cosmo Plus 8100, Respironics/Philips product. Used to provide spirometric recall (Z-1275-2010) | Philips Healthcare Inc. | 2010-04-08 |
| REFURBISHED TIDALWAVE SP 710, REFURBISHED, Respironics/Philips product. Intended use of th recall (Z-1291-2010) | Philips Healthcare Inc. | 2010-04-08 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TCO2M MODEL 818 MONITOR (P810022/S014) | Novametrix Medical Systems, Inc. | 1987-10-09 |
| TCO2M MODEL 818 MONITOR (P810022/S013) | Novametrix Medical Systems, Inc. | 1987-01-29 |
| TCO2M MODEL 818 MONITOR (P810022/S012) | Novametrix Medical Systems, Inc. | 1986-06-05 |
| TCO2M MODEL 818 MONITOR (P810022/S011) | Novametrix Medical Systems, Inc. | 1985-11-21 |
| TCO2M MODEL 818 MONITOR (P810022/S009) | Novametrix Medical Systems, Inc. | 1985-09-03 |
| TCO2M MODEL 818 MONITOR (P810022/S010) | Novametrix Medical Systems, Inc. | 1985-07-01 |
| TCO2M MODEL 818 MONITOR (P810022/S008) | Novametrix Medical Systems, Inc. | 1985-03-11 |
| TCO2M MODEL 818 MONITOR (P810022/S007) | Novametrix Medical Systems, Inc. | 1984-12-04 |