BINOCULAR INDIRECT OPHTHALMOSCOPE— 510(k) K843304

Name: FDA 510(k) clearance K843304
Creator: U.S. Food and Drug Administration
Published: 1984-11-21

Substantially Equivalent

Mentor O & O, Inc.

FDA 510(k) clearance K843304 for BINOCULAR INDIRECT OPHTHALMOSCOPE, Substantially Equivalent on 1984-11-21. Applicant: Mentor O & O, Inc.. Device class: 2.

Clearance details

Applicant: Mentor O & O, Inc.
Product code: Code HLI
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 1984-08-23
Decision date: 1984-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hingham, MA, US

Download summary PDF View on FDA.gov ↗

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