Epitomee— 510(k) K240544

Substantially Equivalent

Epitomee Medical , Ltd.

FDA 510(k) clearance K240544 for Epitomee, Substantially Equivalent on 2024-09-13. Applicant: Epitomee Medical , Ltd..

Clearance details

Applicant: Epitomee Medical , Ltd.
Product code: Code QFQ
Advisory panel: Gastroenterology, Urology
Date received: 2024-02-27
Decision date: 2024-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea, IL

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