Flyte— 510(k) K212655
Substantially EquivalentPelvital USA, Inc.
FDA 510(k) clearance K212655 for Flyte, Substantially Equivalent on 2021-09-21. Applicant: Pelvital USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Pelvital USA, Inc.
- Product code
- Code HIR
- Device class
- Class 2
- Regulation
- 21 CFR 884.1425
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Minneapolis, MN, US
Recent devices under product code HIR
view allMore clearances from Pelvital USA, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.