Company ยท US
Respironics Novametrix, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2011. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 2, 2011 | K103578 | PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST Respironics Novametrix, LLC | BZK |
| Aug 21, 2009 | K092217 | MERCURY VCO2 Respironics Novametrix, Inc. | BZK |
| Jul 28, 2009 | K091459 | PHILIPS NM3 MONITOR, MODEL 7900 Respironics Novametrix, LLC | BZK |
| Jun 20, 2008 | K080652 | MERCURY VCO2 MODULE WITH CAPNOSTAT 5 Respironics Novametrix, LLC | BZK |
| Jan 12, 2006 | K053174 | LOFLO C5 CO2 SENSOR Respironics Novametrix, LLC | CCK |
| Nov 19, 2004 | K042601 | CAPNOSTAT 5 Respironics Novametrix, Inc. | CCK |
| Aug 26, 2004 | K032971 | TIDAL WAVE SP MODEL 710/715 AND 715 Respironics Novametrix, Inc. | DQA |
| Aug 23, 2004 | K032949 | SPOT CHECK PULSE OXIMETER,512/513 Respironics Novametrix, Inc. | DQA |
| Jun 18, 2004 | K041450 | MODIFICATION TO NICO WITH MARS, MODEL 7300 Respironics Novametrix, Inc. | CCK |
| May 21, 2004 | K032755 | MODEL 509M PULSE OXIMETER, MODEL 509M Respironics Novametrix, Inc. | DQA |
| Oct 7, 2003 | K030886 | NICO WITH MARS, MODEL 7300 Respironics Novametrix, Inc. | CCK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2011 | Respironics Novametrix, LLC. FloTrak Elite modules
FloTrak Elite P/N 1044971
FloTrak Elite P/N 1051005 Terminated |
BZK | K080652 K091459 +1 |
| 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 | K080652 K091459 +1 |
| 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 |
K080652 K091459 +1 | |
| 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 |
K080652 K091459 +1 | |
| Sep 29, 2006 | Respironics Novametrix, LLC. NICO Model 7300
Cardiopulmonary Management System Terminated |
CCK | K030886 K041450 +1 |
| Jul 20, 2004 | Respironics Novametrix, Inc. Model 509M Pulse Oximetry Interface Module
Software versions 2.0 or 2.5 Terminated |
DQA | K000794 K032755 +1 |