INTERACOUSTICS. HEARING AID ANALYZER— 510(k) K941848

Name: FDA 510(k) clearance K941848
Creator: U.S. Food and Drug Administration
Published: 1994-05-23

Substantially Equivalent

Precision Acoustics Ind., Inc.

FDA 510(k) clearance K941848 for INTERACOUSTICS. HEARING AID ANALYZER, Substantially Equivalent on 1994-05-23. Applicant: Precision Acoustics Ind., Inc.. Device class: 2.

Clearance details

Applicant: Precision Acoustics Ind., Inc.
Product code: Code ETW
Device class: Class 2
Regulation: 21 CFR 874.3310
Advisory panel: Ear, Nose, Throat
Date received: 1994-04-14
Decision date: 1994-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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