Medical Device Manufacturer · US , Southfield , MI

Rg Ent., Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1996

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Rg Ent., Inc. Cardiovascular ✕

2 devices

1-2 of 2

Cleared Jun 29, 2006

GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE)

Cardiovascular · 408d

Cleared Feb 24, 2006

GERATHERM SOS-RESCUE BLANKET

Cardiovascular · 301d