Device Classification Name |
monitor, physiological, patient(with arrhythmia detection or alarms)
|
510(k) Number |
K070791 |
Device Name |
PM SERIES PATIENT MONITORS, MODELS PM-9000 EXPRESS AND PM-8000 EXPRESS |
Applicant |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
55 NORTHERN BLVD., SUITE 200 |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
SUSAN D GOLDSTEIN-FALK |
Correspondent |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
55 NORTHERN BLVD., SUITE 200 |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
SUSAN D GOLDSTEIN-FALK |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 03/22/2007 |
Decision Date | 06/26/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|