510(k) K163339

SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 by Spectralmd, Inc. — Product Code DPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2017
Date Received
November 28, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Blood-Flow, Extravascular
Device Class
Class II
Regulation Number
870.2120
Review Panel
CV
Submission Type