Medical Device Manufacturer · US , Chicago , IL

Advanced Cooling Therapy, Inc. D/B/A Attune Medical - FDA 510(k) Clea...

3 submissions · 2 cleared · Since 2018

Recent clearances: EnsoETM, EnsoETM

3

Total

2

Cleared

1

Denied

FDA 510(k) Regulatory Record - Advanced Cooling Therapy, Inc. D/B/A Attune Medical Cardiovascular ✕

3 devices

1-3 of 3

Not Cleared Sep 13, 2023

DEN230021 · QXV

Cardiovascular · 167d

Cleared May 17, 2018

Cardiovascular · 56d

Cleared Feb 28, 2018

Cardiovascular · 30d