#SM-3001 OPHTHA OTOSC SET SUBSETS SOLD— 510(k) K852953

Name: FDA 510(k) clearance K852953
Creator: U.S. Food and Drug Administration
Published: 1985-09-06

Substantially Equivalent

Design Med. Corp.

FDA 510(k) clearance K852953 for #SM-3001 OPHTHA OTOSC SET SUBSETS SOLD, Substantially Equivalent on 1985-09-06. 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: 1985-07-11
Decision date: 1985-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HLJ

view all

K142486 — HEINE BETA 200, HEINE BETA 200 S, HEINE K 1802015-05-18
K142837 — HEINE SIGMA 250 & HEINE SIGMA 250 M22015-01-29
K131959 — HEINE MINI 3000(R) OPHTHALMOSCOPE2014-03-07
K131961 — HEINE BETA 200(R) OPHTHALMOSCOPE2013-12-04
K131719 — OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS2013-10-30

More clearances from Design Med. Corp.

view all

K852334 — MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN)1985-06-18
K843897 — POCKET OPHTHALMOSCOPE GH1984-11-27

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