Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)— 510(k) K233362
Substantially EquivalentPelvital USA, Inc.
FDA 510(k) clearance K233362 for Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0), Substantially Equivalent on 2023-12-29. 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
- Eagan, MN, US
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