FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM— 510(k) K011877

Name: FDA 510(k) clearance K011877
Creator: U.S. Food and Drug Administration
Published: 2001-09-26

Substantially Equivalent

Carl Zeiss Jena GmbH

FDA 510(k) clearance K011877 for FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM, Substantially Equivalent on 2001-09-26. Applicant: Carl Zeiss Jena GmbH. Device class: 2.

Clearance details

Applicant: Carl Zeiss Jena GmbH
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2001-06-15
Decision date: 2001-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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