EYECHEK— 510(k) K964290

Name: FDA 510(k) clearance K964290
Creator: U.S. Food and Drug Administration
Published: 1997-01-09

Substantially Equivalent

Reichert Ophthalmic Instruments, Div. Leica, Inc.

FDA 510(k) clearance K964290 for EYECHEK, Substantially Equivalent on 1997-01-09. Applicant: Reichert Ophthalmic Instruments, Div. Leica, Inc.. Device class: 1.

Clearance details

Applicant: Reichert Ophthalmic Instruments, Div. Leica, Inc.
Product code: Code HLQ
Device class: Class 1
Regulation: 21 CFR 886.1350
Advisory panel: Ophthalmic
Date received: 1996-10-28
Decision date: 1997-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Depew, NY, US

Download summary PDF View on FDA.gov ↗

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