Device Classification Name |
monitor, physiological, patient (without arrhythmia detection or alarms)
|
510(k) Number |
K211475 |
Device Name |
Vital Signs Monitors |
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 | 870.2300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/12/2021 |
Decision Date | 10/05/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|