CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ— 510(k) K994340

Name: FDA 510(k) clearance K994340
Creator: U.S. Food and Drug Administration
Published: 2000-09-20

Substantially Equivalent

Hai Laboratories, Inc.

FDA 510(k) clearance K994340 for CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ, Substantially Equivalent on 2000-09-20. Applicant: Hai Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Hai Laboratories, Inc.
Product code: Code HLI
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 1999-12-23
Decision date: 2000-09-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Sound Beach, NY, 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

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