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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 K101539
Device Name VITAL SIGNS MONITOR MODEL M3B
Applicant
EDAN INSTRUMENTS, INC.
NANHAI ROAD 1019#, SHEKOU,
SHENZHEN, GUANGDONG,  CN 51067
Applicant Contact RANDY JIANG
Correspondent
EDAN INSTRUMENTS, INC.
NANHAI ROAD 1019#, SHEKOU,
SHENZHEN, GUANGDONG,  CN 51067
Correspondent Contact RANDY JIANG
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
CCK  
Date Received06/03/2010
Decision Date 11/24/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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