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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 K063641
Device Name PC-60, NON-INVASIVEPULSE OXIMETER
Applicant
SHENZHEN CREATIVE INDUSTRY CO., LTD
340 SHADY GROVE RD
FLINTVILLE,  TN  37335
Applicant Contact MACK CHARLES
Correspondent
SHENZHEN CREATIVE INDUSTRY CO., LTD
340 SHADY GROVE RD
FLINTVILLE,  TN  37335
Correspondent Contact MACK CHARLES
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/07/2006
Decision Date 07/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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