POCKET OPHTHALMOSCOPE GH— 510(k) K843897

Substantially Equivalent

Design Med. Corp.

FDA 510(k) clearance K843897 for POCKET OPHTHALMOSCOPE GH, Substantially Equivalent on 1984-11-27. Applicant: Design Med. Corp.. Device class: 2.

Clearance details

Applicant: Design Med. Corp.
Product code: Code HLJ
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 1984-10-03
Decision date: 1984-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, IL, 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.