RIONET HEARING AID HB-53W— 510(k) K931320

Name: FDA 510(k) clearance K931320
Creator: U.S. Food and Drug Administration
Published: 1993-05-05

Substantially Equivalent

Rion Co. Ltd. Dba Rion Acoustic Device

FDA 510(k) clearance K931320 for RIONET HEARING AID HB-53W, Substantially Equivalent on 1993-05-05. Applicant: Rion Co. Ltd. Dba Rion Acoustic Device. Device class: 1.

Clearance details

Applicant: Rion Co. Ltd. Dba Rion Acoustic Device
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1993-03-16
Decision date: 1993-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bristol, PA, US

Download summary PDF View on FDA.gov ↗

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