Medical Device Manufacturer · US , Mchenry , IL

Etymotic Research - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1984

Recent clearances: ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Etymotic Research Ear, Nose, Throat ✕

7 devices

1-7 of 7

Cleared Jul 03, 2001

ETYMOTIC RESEARCH ER-10D OAE PROBE

Ear, Nose, Throat · 82d

Cleared Mar 12, 2001

ERO SCAN OAE TEST SYSTEM

Ear, Nose, Throat · 53d

Cleared Mar 23, 1998

ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)

Ear, Nose, Throat · 40d

Cleared Sep 29, 1993

CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT

Ear, Nose, Throat · 238d

Cleared Jun 18, 1993

TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES

Ear, Nose, Throat · 165d

Cleared Apr 23, 1986

ER-7C CLINICAL PROBE MICROPHONE

Ear, Nose, Throat · 29d

Cleared Sep 07, 1984

K-BASS LO FREQUENCY HEARING AID

Ear, Nose, Throat · 28d