Device Classification Name |
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
|
510(k) Number |
K152902 |
Device Name |
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) |
Applicant |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
MINDRAY BUILDING, KEJI 12TH ROAD SOUTH, |
HIGH-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, |
HIGH-TECH INDUSTRIAL PARK, NANSHAN |
SHENZHEN,
CN
518057
|
|
Correspondent Contact |
YANHONG BAI |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 10/01/2015 |
Decision Date | 02/18/2016 |
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
|
|
|