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FDA 510(k), K120949, INFRASCANNER
FDA 510(k), K120949, INFRASCANNER
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510(K) Number: K120949
Device Name: INFRASCANNER
Manufacturer: INFRASCAN, INC.
Device Classification Name: infrared hematoma detector
Regulation Number: 882.1935
Classification Product Code: OPT
Date Received: 03/30/2012
Decision Date: 01/11/2013
Regulation Medical Specialty: Ophthalmic
Device Name: INFRASCANNER
Manufacturer: INFRASCAN, INC.
Device Classification Name: infrared hematoma detector
Regulation Number: 882.1935
Classification Product Code: OPT
Date Received: 03/30/2012
Decision Date: 01/11/2013
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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