Elitone for Men— 510(k) K253285

Substantially Equivalent

Elidah, Inc.

FDA 510(k) clearance K253285 for Elitone for Men, Substantially Equivalent on 2026-01-23. Applicant: Elidah, Inc.. Device class: 2.

Clearance details

Applicant
Elidah, Inc.
Product code
Code QAJ
Device class
Class 2
Regulation
21 CFR 876.5330
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Newtown, CT, US
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