CONFOSCAN 2 CONFOCAL MICROSCOPE— 510(k) K012416

Name: FDA 510(k) clearance K012416
Creator: U.S. Food and Drug Administration
Published: 2001-10-26

Substantially Equivalent

Nidek Technologies Srl

FDA 510(k) clearance K012416 for CONFOSCAN 2 CONFOCAL MICROSCOPE, Substantially Equivalent on 2001-10-26. Applicant: Nidek Technologies Srl. Device class: 2.

Clearance details

Applicant: Nidek Technologies Srl
Product code: Code HJO
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 2001-07-30
Decision date: 2001-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, CA, 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.