AUTOMATIC VISUAL FIELD PLOTTER AP-125— 510(k) K961090

Name: FDA 510(k) clearance K961090
Creator: U.S. Food and Drug Administration
Published: 1996-06-17

Substantially Equivalent

Kowa Optimed, Inc.

FDA 510(k) clearance K961090 for AUTOMATIC VISUAL FIELD PLOTTER AP-125, Substantially Equivalent on 1996-06-17. Applicant: Kowa Optimed, Inc.. Device class: 1.

Clearance details

Applicant: Kowa Optimed, Inc.
Product code: Code HPT
Device class: Class 1
Regulation: 21 CFR 886.1605
Advisory panel: Ophthalmic
Date received: 1996-03-19
Decision date: 1996-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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