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FDA 510(k), K102651, ISCREEN VISION SCREENER
FDA 510(k), K102651, ISCREEN VISION SCREENER
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510(K) Number: K102651
Device Name: ISCREEN VISION SCREENER
Manufacturer: ISCREEN VISION, INC.
Device Classification Name: camera, ophthalmic, ac-powered
Regulation Number: 886.1120
Classification Product Code: HKI
Date Received: 09/14/2010
Decision Date: 01/12/2011
Regulation Medical Specialty: Ophthalmic
Device Name: ISCREEN VISION SCREENER
Manufacturer: ISCREEN VISION, INC.
Device Classification Name: camera, ophthalmic, ac-powered
Regulation Number: 886.1120
Classification Product Code: HKI
Date Received: 09/14/2010
Decision Date: 01/12/2011
Regulation Medical Specialty: Ophthalmic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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