K240805

Substantially Equivalent

Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)

Applicant: Pelvital USA, Inc.
Product code: HIR
Advisory panel: Obstetrics/Gynecology
Date received: 2024-03-25
Decision date: 2024-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eagan, MN, US

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