ensoETM
FDA 510(k) clearance DEN230021 · decided 2023-09-13
Clearance details
- K-number
- DEN230021
- Device name
- ensoETM
- Applicant
- Advanced Cooling Therapy, Inc. D/B/A Attune Medical
- Decision
- Unknown
- Date received
- 2023-03-30
- Decision date
- 2023-09-13
- Days to decision
- 167 days
- Clearance type
- Direct
- Product code
- QXV
- Device class
- 2
- Regulation number
- 870.5720
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Advanced Cooling Therapy
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.