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FDA 510(k), K120057, ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)
FDA 510(k), K120057, ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)
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510(K) Number: K120057
Device Name: ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)
Manufacturer: DAWN REILLY-O'DELL
Device Classification Name: Ophthalmoscope, Ac-Powered
Regulation Number: HLI
Classification Product Code: 01/09/2012
Date Received: 05/11/2012
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
Device Name: ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)
Manufacturer: DAWN REILLY-O'DELL
Device Classification Name: Ophthalmoscope, Ac-Powered
Regulation Number: HLI
Classification Product Code: 01/09/2012
Date Received: 05/11/2012
Decision Date: Substantially Equivalent (SESE)
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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