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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, physiological, patient(with arrhythmia detection or alarms)
510(k) Number K120727
Device Name MFM-CMS CENTRAL MONITORING SYSTEM
Applicant
EDAN INSTRUMENTS INC
3/F-B, NANSHAN MEDICAL
EQUIPMENTS PARK
SHENZHEN,  CN 518067
Applicant Contact RANDY JIANG
Correspondent
EDAN INSTRUMENTS INC
3/F-B, NANSHAN MEDICAL
EQUIPMENTS PARK
SHENZHEN,  CN 518067
Correspondent Contact RANDY JIANG
Regulation Number870.1025
Classification Product Code
MHX  
Date Received03/09/2012
Decision Date 06/21/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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