FDA Product Code
FDA Product Code QXV — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5720
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN230021 | ensoETM | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | 2023-09-13 | Direct | — |
Product code QXV · Class II · Cardiovascular. Data: openFDA.