Flyte— 510(k) K210764

Substantially Equivalent

Pelvital USA, Inc.

FDA 510(k) clearance K210764 for Flyte, Substantially Equivalent on 2021-04-13. Applicant: Pelvital USA, Inc..

Clearance details

Applicant: Pelvital USA, Inc.
Product code: Code HIR
Advisory panel: Obstetrics/Gynecology
Date received: 2021-03-15
Decision date: 2021-04-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

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