BEHIND-THE-EAR MASKING AMPLIFIER,735S— 510(k) K780546

Name: FDA 510(k) clearance K780546
Creator: U.S. Food and Drug Administration
Published: 1978-04-10

Substantially Equivalent

Danavox, Inc.

FDA 510(k) clearance K780546 for BEHIND-THE-EAR MASKING AMPLIFIER,735S, Substantially Equivalent on 1978-04-10. Applicant: Danavox, Inc.. Device class: 2.

Clearance details

Applicant: Danavox, Inc.
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 1978-04-05
Decision date: 1978-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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