Medical Device Manufacturer · US , Carlsbad , CA

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

11 submissions · 11 cleared · Since 2002

11

Total

11

Cleared

0

Denied

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

11 devices

1-11 of 11

Cleared Jan 13, 2012

V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE

Anesthesiology · 367d

Cleared Aug 19, 2011

V200 INTELLI-TRAK OPTION

Anesthesiology · 150d

Cleared Dec 22, 2010

V200 VENTILATOR

Anesthesiology · 153d

Cleared Jan 09, 2009

V60 VENTILATOR, MODEL V8000

Anesthesiology · 119d

Cleared Dec 12, 2007

ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000

Anesthesiology · 103d

Cleared Jul 30, 2007

ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000

Anesthesiology · 90d

Cleared Jul 08, 2005

ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000

Anesthesiology · 53d

Cleared Jun 18, 2004

ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000

Anesthesiology · 22d

Cleared Mar 16, 2004

PLV CONTINUUM VENTILATOR, MODEL P2000

Anesthesiology · 78d

Cleared Nov 20, 2003

PLV CONTINUUM VENTILATOR, MODEL P1000

Anesthesiology · 458d

Cleared Nov 06, 2002

ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS

Anesthesiology · 30d