DEN230021
- 510(k) number
- DEN230021
- Device name
- ensoETM
- Applicant
- Advanced Cooling Therapy, Inc. D/B/A Attune Medical IL · US
- Product code
- QXV — Temperature Regulation Device For Esophageal Protect
- Decision date
- 2023-09-13
- Date received
- 2023-03-30
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Cardiovascular
Official FDA record: DEN230021
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.