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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 K113653
Device Name PATIENT MONITOR
Applicant
EDAN INSTRUMENTS, INC.
EQUIPMENTS PARK, NANHAI RD
1019 NO.
SHENZHEN,  CN 518067
Applicant Contact RANDY JIANG
Correspondent
EDAN INSTRUMENTS, INC.
EQUIPMENTS PARK, NANHAI RD
1019 NO.
SHENZHEN,  CN 518067
Correspondent Contact RANDY JIANG
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DQA   DRT   DSA   DSI   DSK  
DXN   FLL  
Date Received12/12/2011
Decision Date 02/06/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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