510(k) K080652 ยท BZK Spirometer, Monitoring (W/Wo Alarm)
MERCURY VCO2 MODULE WITH CAPNOSTAT 5
| Applicant | Respironics Novametrix, LLC, Wallingford CT, US |
| Decision | Substantially Equivalent, Jun 20, 2008 |
| Received | Mar 7, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080652
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2011 | Respironics Novametrix, LLC. PHILIPS NM3 Monitor Model Number: 7900
PHILIPS NM3 Monitor, English
Part Number: 1051674
PHILIPS NM3 Monitor, English, Refurbished
Part Number : U1051674
PHILIPS NM3 Monitor, English, Demo Unit
Part N Terminated |
BZK | None listed |
| Sep 30, 2011 | Respironics Novametrix, LLC. FloTrak Elite modules
FloTrak Elite P/N 1044971
FloTrak Elite P/N 1051005 Terminated |
BZK | None listed |
| May 10, 2011 | Respironics Novametrix, LLC. Philips NM3 Monitors, Model 7900
PHILIPS NM3 Monitor, English - P/N 1051674
PHILIPS NM3 Monitor, English Refurbished - P/N U1051674
PHILIPS NM3 Monitor, English, Demo Unit - P/N DU1051674
PHILIPS NM3 Terminated |
None listed | |
| May 10, 2011 | Respironics Novametrix, LLC. Philips FloTrak Elite modules:
FloTrak Elite P/N 1044971
FloTrak Elite P/N 1051005
NM3 is a multi-parameter patient monitor that utilizes the FloTrak Elite module to perform some of the calculation Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.