GSI SA60 DPOAE SYSTEM— 510(k) K970324

Substantially Equivalent

Grason-Stadler, Inc.

FDA 510(k) clearance K970324 for GSI SA60 DPOAE SYSTEM, Substantially Equivalent on 1997-06-06. Applicant: Grason-Stadler, Inc.. Device class: 2.

Clearance details

Applicant: Grason-Stadler, Inc.
Product code: Code ETW
Device class: Class 2
Regulation: 21 CFR 874.3310
Advisory panel: Ear, Nose, Throat
Date received: 1997-01-27
Decision date: 1997-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milford, NH, US

Download summary PDF View on FDA.gov ↗

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