BERA SH 221 BRIAN STEM AUDIOMETER— 510(k) K830173

Name: FDA 510(k) clearance K830173
Creator: U.S. Food and Drug Administration
Published: 1983-05-25

Substantially Equivalent

Jedmed Instrument Co.

FDA 510(k) clearance K830173 for BERA SH 221 BRIAN STEM AUDIOMETER, Substantially Equivalent on 1983-05-25. Applicant: Jedmed Instrument Co.. Device class: 1.

Clearance details

Applicant: Jedmed Instrument Co.
Product code: Code GNJ
Device class: Class 1
Regulation: 21 CFR 866.3205
Advisory panel: Microbiology
Date received: 1983-01-18
Decision date: 1983-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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