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

Engineered Medical Systems has 22 FDA 510(k) cleared anesthesiology devices. Based in Indianapolis, US.

Historical record: 22 cleared submissions from 1987 to 2003.

Browse the complete list of FDA 510(k) cleared anesthesiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Engineered Medical Systems
22 devices
1-22 of 22
Cleared Dec 01, 2003
MULTI-STRAP FULL FACE MASK
K023683 · BZD
Anesthesiology · 395d
Cleared Jul 30, 2002
TRACH VOX
K013728 · JOH
Anesthesiology · 263d
Cleared Apr 19, 2002
EMS ELECTROSTATIC FLITER AND HME COMBINATION
K013122 · CAH
General Hospital · 212d
Cleared Mar 14, 2002
EMS HEPA FILTER AND HME COMBINATIONS
K013089 · CAH
General Hospital · 178d
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 21, 1993
EMS BIOPSY INSTRUMENT
K930083 · KNW
Gastroenterology & Urology · 104d
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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