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 Number | 870.1025
|
Classification Product Code |
|
Date Received | 03/09/2012 |
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
|
|
|