OTOSCOPE A-34— 510(k) K950788

Substantially Equivalent

Neitz Instruments Company, Ltd.

FDA 510(k) clearance K950788 for OTOSCOPE A-34, Substantially Equivalent on 1995-05-03. Applicant: Neitz Instruments Company, Ltd.. Device class: 1.

Clearance details

Applicant: Neitz Instruments Company, Ltd.
Product code: Code ERA
Device class: Class 1
Regulation: 21 CFR 874.4770
Advisory panel: Ear, Nose, Throat
Date received: 1995-02-21
Decision date: 1995-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

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