PROFESSIONAL INDIRECT OPHTHALMOSCOPE— 510(k) K912397

Name: FDA 510(k) clearance K912397
Creator: U.S. Food and Drug Administration
Published: 1991-10-23

Substantially Equivalent

Clement Clarke, Inc.

FDA 510(k) clearance K912397 for PROFESSIONAL INDIRECT OPHTHALMOSCOPE, Substantially Equivalent on 1991-10-23. Applicant: Clement Clarke, Inc.. Device class: 2.

Clearance details

Applicant: Clement Clarke, Inc.
Product code: Code HLI
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 1991-05-28
Decision date: 1991-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: England, GB

Download summary PDF View on FDA.gov ↗

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