INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV— 510(k) K951338

Name: FDA 510(k) clearance K951338
Creator: U.S. Food and Drug Administration
Published: 1995-04-07

Substantially Equivalent

Neitz Instruments Company, Ltd.

FDA 510(k) clearance K951338 for INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV, Substantially Equivalent on 1995-04-07. Applicant: Neitz Instruments Company, Ltd.. Device class: 2.

Clearance details

Applicant: Neitz Instruments Company, Ltd.
Product code: Code HLI
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 1995-03-24
Decision date: 1995-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

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