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FDA 510(k), K163339, SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0
FDA 510(k), K163339, SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0
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510(K) Number: K163339
Device Name: SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0
Manufacturer: J. MICHAEL DIMAIO
Device Classification Name: Probe, Blood-Flow, Extravascular
Regulation Number: DPT
Classification Product Code: 11/28/2016
Date Received: 08/17/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0
Manufacturer: J. MICHAEL DIMAIO
Device Classification Name: Probe, Blood-Flow, Extravascular
Regulation Number: DPT
Classification Product Code: 11/28/2016
Date Received: 08/17/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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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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