MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN)— 510(k) K852334

Name: FDA 510(k) clearance K852334
Creator: U.S. Food and Drug Administration
Published: 1985-06-18

Substantially Equivalent

Design Med. Corp.

FDA 510(k) clearance K852334 for MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN), Substantially Equivalent on 1985-06-18. 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: 1985-05-31
Decision date: 1985-06-18
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.