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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter, Tissue Saturation
510(k) Number K061848
Device Name HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1
Applicant
Hypermed, Inc.
11 Mystic Ave.
Winchester,  MA  01890
Applicant Contact CHAS BURR
Correspondent
Hypermed, Inc.
11 Mystic Ave.
Winchester,  MA  01890
Correspondent Contact CHAS BURR
Regulation Number870.2700
Classification Product Code
MUD  
Date Received06/30/2006
Decision Date 11/08/2006
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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