FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
ensoETM
K Number: DEN230021
·
Decision Sep 13, 2023
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
3
Review Days
167
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ensoETM
- K Number
- DEN230021
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 870.5720
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Applicant
- Advanced Cooling Therapy, Inc. D/B/A Attune Medical
- Date Received
- March 30, 2023
- Decision Date
- September 13, 2023
- Product Code
- QXV
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QXV | Temperature Regulation Device For Esophageal Protection During Cardiac Ablation | FDA class 2 | Cardiovascular |