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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 K103613
Device Name INPECTRA STO2 SPOT CHECK
Applicant
Hutchinson Technology, Inc.
40 W. Highland Park Dr. NE
Hutchinson,  MN  55350
Applicant Contact COLIN M MCGRAW
Correspondent
Hutchinson Technology, Inc.
40 W. Highland Park Dr. NE
Hutchinson,  MN  55350
Correspondent Contact COLIN M MCGRAW
Regulation Number870.2700
Classification Product Code
MUD  
Date Received12/09/2010
Decision Date 03/02/2011
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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