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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 Rd. 1019#, Shekou,
Shenzhen, Guangdong,  CN 51067
Applicant Contact RANDY JIANG
Correspondent
Edan Instruments, Inc.
Nanhai Rd. 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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