HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134— 510(k) K950797

Name: FDA 510(k) clearance K950797
Creator: U.S. Food and Drug Administration
Published: 1995-03-28

Substantially Equivalent

Neitz Instruments Company, Ltd.

FDA 510(k) clearance K950797 for HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134, Substantially Equivalent on 1995-03-28. Applicant: Neitz Instruments Company, Ltd.. Device class: 2.

Clearance details

Applicant: Neitz Instruments Company, Ltd.
Product code: Code HLJ
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 1995-02-21
Decision date: 1995-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

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