NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON
FDA 510(k) clearance K910019 · decided 1991-03-26
Clearance details
- K-number
- K910019
- Device name
- NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON
- Applicant
- Novametrix Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-01-03
- Decision date
- 1991-03-26
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- CCK
- Device class
- 2
- Regulation number
- 868.1400
- 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 |
|---|---|---|
| 100-120V Capnogard 1265, Respironics/Philips product. Intended to be used for monitoring e recall (Z-1266-2010) | Philips Healthcare Inc. | 2010-04-08 |
| Spanish Capnogard 1265, Respironics/Philips product. Intended to be used for monitoring en recall (Z-1267-2010) | Philips Healthcare Inc. | 2010-04-08 |
| 100-120V Capnogard 1265, Refurbished, Respironics/Philips product. Intended to be used for recall (Z-1286-2010) | 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 |