CATARACTSCREENER CT - S— 510(k) K972440

Name: FDA 510(k) clearance K972440
Creator: U.S. Food and Drug Administration
Published: 1997-09-30

Substantially Equivalent

Neitz Instruments Company, Ltd.

FDA 510(k) clearance K972440 for CATARACTSCREENER CT - S, Substantially Equivalent on 1997-09-30. Applicant: Neitz Instruments Company, Ltd.. Device class: 2.

Clearance details

Applicant: Neitz Instruments Company, Ltd.
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 1997-06-30
Decision date: 1997-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

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