VIO System (V-1000)— 510(k) K232789
Substantially EquivalentEnspectra Health, Inc.
FDA 510(k) clearance K232789 for VIO System (V-1000), Substantially Equivalent on 2023-12-22. Applicant: Enspectra Health, Inc.. Device class: 2.
Clearance details
- Applicant
- Enspectra Health, Inc.
- Product code
- Code QZN
- Device class
- Class 2
- Regulation
- 21 CFR 878.4580
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mountain View, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.