Medical Device Manufacturer · US , Wallingford , CT

Respironics Novametrix, Inc. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2003

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Respironics Novametrix, Inc. Anesthesiology ✕

7 devices

1-7 of 7

Cleared Aug 21, 2009

Anesthesiology · 30d

Cleared Nov 19, 2004

Anesthesiology · 56d

Cleared Aug 26, 2004

TIDAL WAVE SP MODEL 710/715 AND 715

Anesthesiology · 339d

Cleared Aug 23, 2004

SPOT CHECK PULSE OXIMETER,512/513

Anesthesiology · 336d

Cleared Jun 18, 2004

MODIFICATION TO NICO WITH MARS, MODEL 7300

Anesthesiology · 17d

Cleared May 21, 2004

MODEL 509M PULSE OXIMETER, MODEL 509M

Anesthesiology · 259d

Cleared Oct 07, 2003

NICO WITH MARS, MODEL 7300

Anesthesiology · 200d