ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)— 510(k) K912581

Name: FDA 510(k) clearance K912581
Creator: U.S. Food and Drug Administration
Published: 1991-12-23

Substantially Equivalent

Carl Zeiss, Inc.

FDA 510(k) clearance K912581 for ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO), Substantially Equivalent on 1991-12-23. Applicant: Carl Zeiss, Inc.. Device class: 2.

Clearance details

Applicant: Carl Zeiss, Inc.
Product code: Code HLI
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 1991-06-12
Decision date: 1991-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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