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 NO. SHEKOU, NANSHAN |
SHENZHEN, GUANGDONG,
CN
518067
|
|
Applicant Contact |
CHERRY SUN |
Correspondent |
EDAN INSTRUMENTS, INC. |
NANHAI RD 1019 NO. SHEKOU, NANSHAN |
SHENZHEN, GUANGDONG,
CN
518067
|
|
Correspondent Contact |
CHERRY SUN |
Regulation Number | 870.1025
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/28/2013 |
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
|
Recalls |
CDRH Recalls
|
|
|