Medical Device Manufacturer · US , Largo , FL

Burke Neutech, Inc. - FDA 510(k) Cleared Devices

7 submissions · 6 cleared · Since 1993

7

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Burke Neutech, Inc. Physical Medicine ✕

5 devices

1-5 of 5

Cleared Apr 10, 1996

SPORTS CONTRAST THERAPY SYSTEM ST 7000

Physical Medicine · 142d

Cleared Jun 07, 1995

CONTRAST 7000 THERAPY SYSTEM

Physical Medicine · 323d

Cleared May 11, 1995

THERMAFLEX, MODEL SD 55 C.P.M.H.

Physical Medicine · 164d

Cleared May 27, 1994

TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM

Physical Medicine · 135d

Cleared May 26, 1993

LSI6000 THERMAL THERAPY SYSTEM

Physical Medicine · 170d