RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM— 510(k) K960229

Name: FDA 510(k) clearance K960229
Creator: U.S. Food and Drug Administration
Published: 1996-03-07

Substantially Equivalent

Resound Corp.

FDA 510(k) clearance K960229 for RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM, Substantially Equivalent on 1996-03-07. Applicant: Resound Corp.. Device class: 2.

Clearance details

Applicant: Resound Corp.
Product code: Code ETW
Device class: Class 2
Regulation: 21 CFR 874.3310
Advisory panel: Ear, Nose, Throat
Date received: 1996-01-17
Decision date: 1996-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

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