SONOTONE BODY AID MODEL ST 1000 BODY WORN— 510(k) K915517

Substantially Equivalent

Sonotone Intl., Inc.

FDA 510(k) clearance K915517 for SONOTONE BODY AID MODEL ST 1000 BODY WORN, Substantially Equivalent on 1992-01-09. Applicant: Sonotone Intl., Inc.. Device class: 1.

Clearance details

Applicant
Sonotone Intl., Inc.
Product code
Code ESD
Device class
Class 1
Regulation
21 CFR 874.3300
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Longwood, FL, US
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