WOODLYN CLASSIC CATARACT ACUITY TEST— 510(k) K843812

Name: FDA 510(k) clearance K843812
Creator: U.S. Food and Drug Administration
Published: 1984-12-11

Substantially Equivalent

Woodlyn, Inc.

FDA 510(k) clearance K843812 for WOODLYN CLASSIC CATARACT ACUITY TEST, Substantially Equivalent on 1984-12-11. Applicant: Woodlyn, Inc.. Device class: 2.

Clearance details

Applicant: Woodlyn, Inc.
Product code: Code HLI
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 1984-09-28
Decision date: 1984-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HLI

view all

K153080 — RTVue XR OCT Avanti with AngioVue Software2016-02-11
K150722 — EnFocus 2300, EnFocus 44002015-12-02
K142953 — OCT-Camera2015-03-04
K141638 — PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE2014-09-17
K133758 — CENTERVUE MACULAR INTEGRITY ASSESSMENT2014-04-23

More clearances from Woodlyn, Inc.

view all

K931303 — WOODLYN OPERATION MICROSCOPE1993-06-25
K920861 — WOODLYN CLASSIC LENSMETER1992-07-30
K900476 — WOODLYN SLIT LAMP MODEL HR-11990-02-21
K900477 — WOODLYN CLASSIC SLIT LAMP MODEL SMM1990-02-21
K900478 — WOODLYN FULL APERTURE TRIAL LENS SET1990-02-21

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