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Advanced Cooling Therapy, Inc. D/B/A Attune Medical
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
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
Filters
Not Cleared
Sep 13, 2023
ensoETM
DEN230021
·
QXV
Cardiovascular
·
167d
Cleared
May 17, 2018
EnsoETM
K180742
·
PLA
Cardiovascular
·
56d
Cleared
Feb 28, 2018
EnsoETM
K180244
·
PLA
Cardiovascular
·
30d
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3
Cardiovascular
3