Medical Device Manufacturer · US , Dekalb , IL

Rockwin Corp. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1994

Recent clearances: HI-69E, HI-69N, HI-69P

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Rockwin Corp. Ear, Nose, Throat ✕

3 devices

1-3 of 3

Cleared Dec 12, 1997

HI-69E, HI-69N, HI-69P

Ear, Nose, Throat · 39d

Cleared May 24, 1995

Ear, Nose, Throat · 293d

Cleared Jan 27, 1994

HEARING AIDS HB-36M, HB-36MS, HB-36MT, HI-67P, EXCEL-1000

Ear, Nose, Throat · 71d