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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 K131971
Device Name IM60/IM70 PATIENT MONITOR
Applicant
Edan Instruments, Inc.
Nanhai Rd. 1019 # Shekou, Nanshan
Shenzhen, Guangdong,  CN 518067
Applicant Contact CHERRY SUN
Correspondent
Edan Instruments, Inc.
Nanhai Rd. 1019 # Shekou, Nanshan
Shenzhen, Guangdong,  CN 518067
Correspondent Contact CHERRY SUN
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
CBQ   CBR   CBS   CCK   CCL  
DQA   DRT   DSA   DSI   DSK   DXN  
FLL   MLD  
Date Received06/28/2013
Decision Date 03/20/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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