The N-SWEAT Patch
FDA 510(k) clearance DEN210055 · decided 2023-04-07
Clearance details
- K-number
- DEN210055
- Device name
- The N-SWEAT Patch
- Applicant
- Candesant Biomedical, Inc.
- Decision
- Unknown
- Date received
- 2021-12-03
- Decision date
- 2023-04-07
- Days to decision
- 490 days
- Clearance type
- Direct
- Product code
- QVX
- Device class
- 2
- Regulation number
- 878.4425
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.