Respironics Novametrix, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 11
- Inspections
- 3
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K103578 | PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST | June 2, 2011 |
| K092217 | MERCURY VCO2 | August 21, 2009 |
| K091459 | PHILIPS NM3 MONITOR, MODEL 7900 | July 28, 2009 |
| K080652 | MERCURY VCO2 MODULE WITH CAPNOSTAT 5 | June 20, 2008 |
| K053174 | LOFLO C5 CO2 SENSOR | January 12, 2006 |
| K042601 | CAPNOSTAT 5 | November 19, 2004 |
| K032971 | TIDAL WAVE SP MODEL 710/715 AND 715 | August 26, 2004 |
| K032949 | SPOT CHECK PULSE OXIMETER,512/513 | August 23, 2004 |
| K041450 | MODIFICATION TO NICO WITH MARS, MODEL 7300 | June 18, 2004 |
| K032755 | MODEL 509M PULSE OXIMETER, MODEL 509M | May 21, 2004 |
| K030886 | NICO WITH MARS, MODEL 7300 | October 7, 2003 |