COHERENT FUNDUSL RETINAL CAMERA— 510(k) K822908

Name: FDA 510(k) clearance K822908
Creator: U.S. Food and Drug Administration
Published: 1983-01-05

Substantially Equivalent

Coherent Medical Division

FDA 510(k) clearance K822908 for COHERENT FUNDUSL RETINAL CAMERA, Substantially Equivalent on 1983-01-05. Applicant: Coherent Medical Division. Device class: 2.

Clearance details

Applicant: Coherent Medical Division
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 1982-09-30
Decision date: 1983-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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