Elitone Device— 510(k) K183585

Substantially Equivalent

Elidah, Inc.

FDA 510(k) clearance K183585 for Elitone Device, Substantially Equivalent on 2019-02-11. Applicant: Elidah, Inc..

Clearance details

Applicant: Elidah, Inc.
Product code: Code QAJ
Advisory panel: Gastroenterology, Urology
Date received: 2018-12-21
Decision date: 2019-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monroe, CT, US

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