Medical Device Manufacturer · US , Dallas , TX

Temptek, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1989

3

Total

3

Cleared

0

Denied

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

3 devices

1-3 of 3

Cleared Jun 19, 1995

Physical Medicine · 223d

Cleared Mar 26, 1990

TEMPTEK T-1000 THERAPEUTIC COOLING UNIT

Physical Medicine · 389d

Cleared May 26, 1989

TEMPTEK 5010 THERMAL COOLING BLANKET

Physical Medicine · 85d