CIRRUS HD-OCT, MODEL 4000— 510(k) K063378

Name: FDA 510(k) clearance K063378
Creator: U.S. Food and Drug Administration
Published: 2007-01-26

Substantially Equivalent

Carl Zeiss Meditec, Inc.

FDA 510(k) clearance K063378 for CIRRUS HD-OCT, MODEL 4000, Substantially Equivalent on 2007-01-26. Applicant: Carl Zeiss Meditec, Inc.. Device class: 2.

Clearance details

Applicant: Carl Zeiss Meditec, Inc.
Product code: Code HLI
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2006-11-08
Decision date: 2007-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin, CA, US

Download summary PDF View on FDA.gov ↗

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