IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP— 510(k) K071299

Name: FDA 510(k) clearance K071299
Creator: U.S. Food and Drug Administration
Published: 2007-08-31

Substantially Equivalent

Digital Healthcare, Ltd.

FDA 510(k) clearance K071299 for IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP, Substantially Equivalent on 2007-08-31. Applicant: Digital Healthcare, Ltd.. Device class: 2.

Clearance details

Applicant: Digital Healthcare, Ltd.
Product code: Code NFJ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2007-05-09
Decision date: 2007-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wake Forest, NC, US

Download summary PDF View on FDA.gov ↗

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