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
1-22 of 22
Cleared Mar 04, 2004
HIOX80 AEROSOL ADAPTER
K032516 · CAF
Anesthesiology · 203d
Cleared Feb 13, 2004
INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
K031745 · BZD
Anesthesiology · 253d
Cleared Aug 25, 2003
LYRA NASAL MASK
K031883 · BZD
Anesthesiology · 68d
Cleared Apr 22, 2003
MODIFICATION TO HIOX
K030943 · CBP
Anesthesiology · 27d
Cleared Jan 24, 2003
PEGASUS NASAL CPAP SYSTEM
K022192 · BZD
Anesthesiology · 203d
Cleared Jul 30, 2002
HI-OX
K020665 · CBP
Anesthesiology · 151d
Cleared Jul 24, 2001
MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT
K012034 · BZD
Anesthesiology · 25d
Cleared Aug 13, 1999
INFANT FLOW SYSTEM
K991972 · BZD
Anesthesiology · 63d
Cleared Feb 24, 1999
INFANT FLOW NCPAP MASKS
K984254 · BZD
Anesthesiology · 89d
Cleared Oct 30, 1998
STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX...
K981366 · BTY
Anesthesiology · 198d
Cleared Jan 30, 1998
INFANT FLOW SYSTEM
K974303 · BZD
Anesthesiology · 74d
Cleared Nov 22, 1994
VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS
K942211 · BTY
Anesthesiology · 201d
Cleared Oct 21, 1993
SENSORMEDICS MODEL 2200 PULMONARY FUNCTION LABS
K923988 · BZG
Anesthesiology · 437d
Cleared Aug 09, 1993
SENSORMEDICS MODEL 6200 AUTOBOX DL
K923989 · BZG
Anesthesiology · 363d
Cleared Feb 17, 1993
OXYSHUTTLE II ,MODIFICATION
K925542 · DQA
Anesthesiology · 121d
Cleared Dec 02, 1992
SENSORMEDICS MODEL 2600 PEDIATRIC PULMOONARY CART
K915833 · BZC
Anesthesiology · 344d
Cleared Dec 01, 1992
MODEL 2900 METABOLIC MEASUREMENT CART
K915686 · BZC
Anesthesiology · 347d
Cleared Oct 26, 1992
SENSORMEDICS MODEL 2130 SPIEOMETRY SYSTEM
K920111 · BZG
Anesthesiology · 290d
Cleared Apr 08, 1992
SENSORMEDICS MODEL 922 SPIROMETER
K920246 · BZG
Anesthesiology · 78d
Cleared Feb 26, 1992
SENSORMEDICS OXYSHUTTLE II(TM)
K913790 · DQA
Anesthesiology · 187d
Cleared Sep 26, 1986
SENSORMEDICS OXYSHUTTLE(TM)
K862617 · DQA
Anesthesiology · 79d
Cleared Jun 15, 1984
PULMONARY FUNCTION SYSTEM
K842041 · BZG
Anesthesiology · 25d
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