Medical Device Manufacturer · US , Mountainside , NJ

Rastronics USA, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1985

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Rastronics USA, Inc. Ear, Nose, Throat ✕

4 devices

1-4 of 4

Cleared Oct 05, 1990

RASTRONICS CCI 8

Ear, Nose, Throat · 140d

Cleared Sep 12, 1990

RASTRONICS CCI 10/3 HEARING AID ANALYSIS

Ear, Nose, Throat · 114d

Cleared Jun 21, 1989

HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS.

Ear, Nose, Throat · 120d

Cleared Sep 27, 1985

FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10

Ear, Nose, Throat · 59d