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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Blood-Flow, Extravascular
510(k) Number K163339
Device Name SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0
Applicant
SPECTRALMD, INC.
2515 MCKINNEY AVENUE
DALLAS,  TX  75201
Applicant Contact J. MICHAEL DIMAIO
Correspondent
SPECTRALMD, INC.
2515 MCKINNEY AVENUE
DALLAS,  TX  75201
Correspondent Contact J. MICHAEL DIMAIO
Regulation Number870.2120
Classification Product Code
DPT  
Date Received11/28/2016
Decision Date 08/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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