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FDA 510(k) K010315, ISCREEN VISION SCREENER, by Iscreen, LLC

FDA 510(k) K010315, ISCREEN VISION SCREENER, by Iscreen, LLC

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510(K) Number: K010315
Device Name: ISCREEN VISION SCREENER
Manufacturer: Iscreen, LLC
Device Classification Name: camera, ophthalmic, ac-powered
Regulation Number: 886.1120
Classification Product Code: HKI
Date Received: 02/02/2001
Decision Date: 06/01/2001
Regulation Medical Specialty: Ophthalmic
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