DIGITAL EYE-FUNDUS CAMERA— 510(k) K120982

Name: FDA 510(k) clearance K120982
Creator: U.S. Food and Drug Administration
Published: 2012-09-28

Substantially Equivalent

Medimaging Integrated Solutions, Inc. (Miis)

FDA 510(k) clearance K120982 for DIGITAL EYE-FUNDUS CAMERA, Substantially Equivalent on 2012-09-28. Applicant: Medimaging Integrated Solutions, Inc. (Miis). Device class: 2.

Clearance details

Applicant: Medimaging Integrated Solutions, Inc. (Miis)
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2012-04-02
Decision date: 2012-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu, CN

Download summary PDF View on FDA.gov ↗

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