INDIRECT OPHTHALMOSCOPE— 510(k) K853891

Substantially Equivalent

Carl Zeiss, Inc.

FDA 510(k) clearance K853891 for INDIRECT OPHTHALMOSCOPE, Substantially Equivalent on 1985-10-04. Applicant: Carl Zeiss, Inc.. Device class: 2.

Clearance details

Applicant: Carl Zeiss, Inc.
Product code: Code HLJ
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 1985-09-19
Decision date: 1985-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thornwood, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.