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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K062149
Device Name SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AND Y SERIES
Applicant
International Business Strategies
1667a Marsh Habor Ln.
Mount Pleasant,  SC  29464
Applicant Contact BILL ROETTGER
Correspondent
International Business Strategies
1667a Marsh Habor Ln.
Mount Pleasant,  SC  29464
Correspondent Contact BILL ROETTGER
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/27/2006
Decision Date 05/31/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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