Device Classification Name |
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
|
510(k) Number |
K171901 |
Device Name |
uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) |
Applicant |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd |
Mindray Building, Keji 12th Road 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 Road South, |
Hi-tech Industrial Park, Nanshan |
Shenzhen,
CN
518057
|
|
Correspondent Contact |
Yanhong Bai |
Regulation Number | 870.1025
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/26/2017 |
Decision Date | 11/15/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|