Device Classification Name |
monitor, physiological, patient(with arrhythmia detection or alarms)
|
510(k) Number |
K150352 |
Device Name |
V Series Monitoring System (including V12 and V21 Monitors) |
Applicant |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
MINDRAY BUILDING, KEJI 12TH RD |
SOUTH, HI-TECH INDUSTRIAL PARK |
NANSHAN,SHENZHEN,
CN
518057
|
|
Applicant Contact |
YANHONG BAI |
Correspondent |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
MINDRAY BUILDING, KEJI 12TH RD |
SOUTH, HI-TECH INDUSTRIAL PARK |
NANSHAN,SHENZHEN,
CN
518057
|
|
Correspondent Contact |
YANHONG BAI |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 02/11/2015 |
Decision Date | 09/02/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|