Medical Device Manufacturer · US , Somerset , PA

Sunrise Medical - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2002

Official Website

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sunrise Medical Anesthesiology ✕

11 devices

1-11 of 11

Cleared Jan 26, 2010

DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES

Anesthesiology · 118d

Cleared Sep 28, 2009

DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST

Anesthesiology · 90d

Cleared Oct 28, 2008

DEVILBISS DV5M SMARTLINK SYSTEM

Anesthesiology · 84d

Cleared Aug 25, 2008

DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES

Anesthesiology · 90d

Cleared Oct 01, 2007

DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES

Anesthesiology · 133d

Cleared Sep 07, 2007

DEVILBISS INTELLIPAP MODEL DV 5 SERIES

Anesthesiology · 79d

Cleared Feb 03, 2006

DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES

Anesthesiology · 77d

Cleared Feb 11, 2005

DEVILBISS AUTOADJUST, MODEL 9054 SERIES

Anesthesiology · 77d

Cleared Jan 14, 2005

DEVILBISS NASAL CPAP MASK, 9354 SERIES

Anesthesiology · 126d

Cleared Feb 20, 2004

BILEVEL CPAP, MODEL 9055 SERIES

Anesthesiology · 233d

Cleared Jun 28, 2002

DEVILBISS PULMO-AIDE COMPACT COMPRESSOR

Anesthesiology · 98d