OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS— 510(k) K093495

Name: FDA 510(k) clearance K093495
Creator: U.S. Food and Drug Administration
Published: 2010-11-19

Substantially Equivalent

American Diagnostic Corp.

FDA 510(k) clearance K093495 for OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS, Substantially Equivalent on 2010-11-19. Applicant: American Diagnostic Corp.. Device class: 2.

Clearance details

Applicant: American Diagnostic Corp.
Product code: Code HLJ
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2009-11-10
Decision date: 2010-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hauppauge, NY, 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 American Diagnostic Corp.

view all

K162589 — Adscope 658 Electronic Stethoscope2017-03-10
K060321 — ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK2006-05-15
K012304 — ADC 656 ELECTRONIC STETHOSCOPE2001-11-01
K962655 — ANEROID AND MERCURIAL SPHYGMOMANOMETERS1997-01-27
K940686 — ELECTRONIC THERMOMETERS1994-07-08

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