Ballancer Platinum (1222)— 510(k) K230385

Substantially Equivalent

Mego Afek

FDA 510(k) clearance K230385 for Ballancer Platinum (1222), Substantially Equivalent on 2023-04-04. Applicant: Mego Afek.

Clearance details

Applicant: Mego Afek
Product code: Code IRP
Advisory panel: Physical Medicine
Date received: 2023-02-14
Decision date: 2023-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kibbuts Afek, IL

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