Medical Device Manufacturer · US , Indianapolis , IN

Engineered Medical Systems - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 1987
22
Total
22
Cleared
0
Denied
FDA 510(k) Regulatory Record - Engineered Medical Systems Anesthesiology
19 devices
1-19 of 19
Cleared Dec 01, 2003
MULTI-STRAP FULL FACE MASK
K023683 · BZD
Anesthesiology · 395d
Cleared Jul 30, 2002
TRACH VOX
K013728 · JOH
Anesthesiology · 263d
Cleared Mar 14, 2002
EMS PULMONARY FUNCTION TESTING FILTER
K013123 · BZG
Anesthesiology · 176d
Cleared Nov 30, 2000
DISPOSABLE PRESSURE MONITOR
K003497 · CAP
Anesthesiology · 17d
Cleared May 26, 2000
SWIVEL ELBOW
K000215 · BZD
Anesthesiology · 123d
Cleared Apr 12, 2000
INCENTIVE SPIROMETER
K000314 · BWF
Anesthesiology · 71d
Cleared Jul 06, 1999
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR...
K991955 · BTM
Anesthesiology · 35d
Cleared Jul 01, 1999
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR...
K991953 · BTM
Anesthesiology · 30d
Cleared Apr 07, 1999
EMS MOUTH TO MASK RESUSCITATORS
K983919 · CBP
Anesthesiology · 154d
Cleared Jan 22, 1999
EMS PEEP VALVES- ADJUSTABLE
K983920 · BYE
Anesthesiology · 79d
Cleared Jan 28, 1998
EMS NASAL CPAP MASK
K972605 · BZD
Anesthesiology · 201d
Cleared Sep 03, 1993
PRESSURE LIMITING ELBOW
K932797 · BTM
Anesthesiology · 86d
Cleared Sep 03, 1993
SINGLE USE MANUAL RESUSCITATOR PEEP VALVE
K932799 · BYE
Anesthesiology · 86d
Cleared Apr 21, 1993
BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCIT
K924671 · BTM
Anesthesiology · 217d
Cleared Apr 06, 1993
BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT
K924610 · BTM
Anesthesiology · 207d
Cleared Nov 13, 1991
EMS SINGLE USE MANUAL RESUSCITATORS
K912203 · BTM
Anesthesiology · 177d
Cleared Oct 23, 1991
EMS PERCUSSOR
K913014 · BYI
Anesthesiology · 107d
Cleared Dec 21, 1987
SEALFLEX MASK
K874746 · BSJ
Anesthesiology · 33d
Cleared Jun 08, 1987
RIBBED CUSHION MASK
K871851 · BSJ
Anesthesiology · 27d
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