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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 K110922
Device Name PATIENT MONITOR
Applicant
EDAN INSTRUMENTS, INC.
3/F-B, NANSHAN MEDICAL
EQUIPMENTS PARK, NANHAI RD1019
SHENZHEN, GUANGDONG,  CN 518067
Applicant Contact RANDY JIANG
Correspondent
EDAN INSTRUMENTS, INC.
3/F-B, NANSHAN MEDICAL
EQUIPMENTS PARK, NANHAI RD1019
SHENZHEN, GUANGDONG,  CN 518067
Correspondent Contact RANDY JIANG
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
CBQ   CBR   CBS   CCK   CCL  
DQA   DRT   DSA   DSF   DSK   DXN  
FLL   MLD  
Date Received04/01/2011
Decision Date 07/20/2011
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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