MERCURY VCO2 MODULE WITH CAPNOSTAT 5
FDA 510(k) clearance K080652 · decided 2008-06-20
Clearance details
- K-number
- K080652
- Device name
- MERCURY VCO2 MODULE WITH CAPNOSTAT 5
- Applicant
- Respironics Novametrix, LLC
- Decision
- Substantially Equivalent
- Date received
- 2008-03-07
- Decision date
- 2008-06-20
- Days to decision
- 105 days
- Clearance type
- Special
- Product code
- BZK
- Device class
- 2
- Regulation number
- 868.1850
- 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 |
|---|---|---|
| PHILIPS NM3 Monitor Model Number: 7900 PHILIPS NM3 Monitor, English Part Number: 1051674 P recall (Z-3287-2011) | Respironics Novametrix, LLC. | 2011-09-30 |
| FloTrak Elite modules FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005 recall (Z-3288-2011) | Respironics Novametrix, LLC. | 2011-09-30 |
| Philips NM3 Monitors, Model 7900 PHILIPS NM3 Monitor, English - P/N 1051674 PHILIPS NM3 Mo recall (Z-2167-2011) | Respironics Novametrix, LLC. | 2011-05-10 |
| Philips FloTrak Elite modules: FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005 NM3 is recall (Z-2168-2011) | Respironics Novametrix, LLC. | 2011-05-10 |