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

1-12 of 19

Cleared Dec 01, 2003

MULTI-STRAP FULL FACE MASK

Anesthesiology · 395d

Cleared Jul 30, 2002

Anesthesiology · 263d

Cleared Mar 14, 2002

EMS PULMONARY FUNCTION TESTING FILTER

Anesthesiology · 176d

Cleared Nov 30, 2000

DISPOSABLE PRESSURE MONITOR

Anesthesiology · 17d

Cleared May 26, 2000

Anesthesiology · 123d

Cleared Apr 12, 2000

INCENTIVE SPIROMETER

Anesthesiology · 71d

Cleared Jul 06, 1999

MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR...

Anesthesiology · 35d

Cleared Jul 01, 1999

MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR...

Anesthesiology · 30d

Cleared Apr 07, 1999

EMS MOUTH TO MASK RESUSCITATORS

Anesthesiology · 154d

Cleared Jan 22, 1999

EMS PEEP VALVES- ADJUSTABLE

Anesthesiology · 79d

Cleared Jan 28, 1998

EMS NASAL CPAP MASK

Anesthesiology · 201d

Cleared Sep 03, 1993

PRESSURE LIMITING ELBOW

Anesthesiology · 86d