TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610
FDA 510(k) clearance K963327 · decided 1996-11-20
Clearance details
- K-number
- K963327
- Device name
- TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610
- Applicant
- Novametrix Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-08-23
- Decision date
- 1996-11-20
- Days to decision
- 89 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 |
|---|---|---|
| Tidal wave, Model 610, Respironics/Philips product. Intended use of the monitors is to pro recall (Z-1273-2010) | Philips Healthcare Inc. | 2010-04-08 |
| Tidal Wave Model 615, Respironics/Philips product. Intended use of the monitors is to prov recall (Z-1283-2010) | Philips Healthcare Inc. | 2010-04-08 |
| Tidal Wave 610, Refurbished, Respironics/Philips product. Intended use of the monitors is recall (Z-1289-2010) | Philips Healthcare Inc. | 2010-04-08 |
| Tidal Wave - 615, Refurbished, Respironics/Philips product. Intended use of the monitors i recall (Z-1294-2010) | 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 |