OTOMET MODEL M-9 HEARING INSTRUMENT— 510(k) K820425

Name: FDA 510(k) clearance K820425
Creator: U.S. Food and Drug Administration
Published: 1982-03-02

Substantially Equivalent

Otomet Corp.

FDA 510(k) clearance K820425 for OTOMET MODEL M-9 HEARING INSTRUMENT, Substantially Equivalent on 1982-03-02. Applicant: Otomet Corp.. Device class: 1.

Clearance details

Applicant: Otomet Corp.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1982-02-16
Decision date: 1982-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.