Medical Device Manufacturer · US , Plano , TX

Epic Medical Equipment Services, Inc. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1996

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Epic Medical Equipment Services, Inc. Anesthesiology ✕

12 devices

1-12 of 12

Cleared Oct 17, 2001

FLEXI-SITE SP02 EAR SENSOR

Anesthesiology · 85d

Cleared May 24, 2001

SPO2 WRAP SENSOR

Anesthesiology · 253d

Cleared Mar 23, 2001

FLEXI-SITE SP02 EAR SENSOR

Anesthesiology · 11d

Cleared Aug 22, 2000

EPIC SPO2 FINGER SENSOR, MODEL E412-20

Anesthesiology · 29d

Cleared Jun 05, 2000

STAT-SHELL DISPOSABLE SP02 SENSOR

Anesthesiology · 83d

Cleared Dec 22, 1999

STAT-SHELL DISPOSABLE SPO2 SENSOR

Anesthesiology · 184d

Cleared Dec 22, 1999

SPO2 WRAP SENSOR

Anesthesiology · 174d

Cleared Apr 09, 1999

EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE,...

Anesthesiology · 88d

Cleared Apr 30, 1998

E100 SERIES SPO2 SENSORS

Anesthesiology · 472d

Cleared Jul 16, 1997

OXIMETER PRE-AMP CABLE

Anesthesiology · 204d

Cleared Feb 21, 1997

FLEXI-SITE (E203-01)/ FLEXI-FIT (E300)

Anesthesiology · 135d

Cleared Sep 12, 1996

E100A PULSE OXIMETER FINGER SENSOR/PROBE

Anesthesiology · 373d