Medical Device Manufacturer · US , Walker , MI

Sensor Medics Corp. - FDA 510(k) Cleared Devices

26 submissions · 26 cleared · Since 1984

26

Total

26

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sensor Medics Corp. Anesthesiology ✕

22 devices

1-12 of 22

Cleared Mar 04, 2004

HIOX80 AEROSOL ADAPTER

Anesthesiology · 203d

Cleared Feb 13, 2004

INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION

Anesthesiology · 253d

Cleared Aug 25, 2003

LYRA NASAL MASK

Anesthesiology · 68d

Cleared Apr 22, 2003

MODIFICATION TO HIOX

Anesthesiology · 27d

Cleared Jan 24, 2003

PEGASUS NASAL CPAP SYSTEM

Anesthesiology · 203d

Cleared Jul 30, 2002

Anesthesiology · 151d

Cleared Jul 24, 2001

MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT

Anesthesiology · 25d

Cleared Aug 13, 1999

INFANT FLOW SYSTEM

Anesthesiology · 63d

Cleared Feb 24, 1999

INFANT FLOW NCPAP MASKS

Anesthesiology · 89d

Cleared Oct 30, 1998

STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX...

Anesthesiology · 198d

Cleared Jan 30, 1998

INFANT FLOW SYSTEM

Anesthesiology · 74d

Cleared Nov 22, 1994

VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS

Anesthesiology · 201d