Ballancer 505 System, Model 1201-AC— 510(k) K150269

Substantially Equivalent

Mego Afek AC , Ltd.

FDA 510(k) clearance K150269 for Ballancer 505 System, Model 1201-AC, Substantially Equivalent on 2015-05-26. Applicant: Mego Afek AC , Ltd..

Clearance details

Applicant: Mego Afek AC , Ltd.
Product code: Code IRP
Advisory panel: Physical Medicine
Date received: 2015-02-04
Decision date: 2015-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kibbutz Afek, IL

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