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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 K113727
Device Name SHENZHEN MED-LINK PULSE OXIMETER PROBE
Applicant
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
144 RESEARCH DRIVE
HAMPTON,  VA  23666
Applicant Contact RHONDA ALEXANDER
Correspondent
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
144 RESEARCH DRIVE
HAMPTON,  VA  23666
Correspondent Contact RHONDA ALEXANDER
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/19/2011
Decision Date 03/21/2013
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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