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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 K124049
Device Name DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM
Applicant
Spectralmd, Inc.
1201 Richardson Dr., Suite 280
Richardson,  TX  75080
Applicant Contact DIANE RUTHERFORD
Correspondent
Spectralmd, Inc.
1201 Richardson Dr., Suite 280
Richardson,  TX  75080
Correspondent Contact DIANE RUTHERFORD
Regulation Number870.2120
Classification Product Code
DPT  
Date Received12/31/2012
Decision Date 04/18/2013
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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