Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)— 510(k) K240805
Substantially EquivalentPelvital USA, Inc.
FDA 510(k) clearance K240805 for Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5), Substantially Equivalent on 2024-08-01. Applicant: Pelvital USA, Inc..
Clearance details
- Applicant
- Pelvital USA, Inc.
- Product code
- Code HIR
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eagan, MN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.