PM-7000 PATIENT MONITOR


Device Classification Name

monitor, physiological, patient(with arrhythmia detection or alarms)

510(k) Number K072346
Device Name PM-7000 PATIENT MONITOR
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

Correspodent Contact susan d goldstein-falk
Regulation Number 870.1025
Classification Product Code
MHX  
Date Received 08/21/2007
Decision Date 11/29/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No