ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID— 510(k) K882633

Name: FDA 510(k) clearance K882633
Creator: U.S. Food and Drug Administration
Published: 1989-01-13

Substantially Equivalent

Ensoniq Corp.

FDA 510(k) clearance K882633 for ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID, Substantially Equivalent on 1989-01-13. Applicant: Ensoniq Corp.. Device class: 1.

Clearance details

Applicant: Ensoniq Corp.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1988-06-27
Decision date: 1989-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

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