HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS)


Device Classification Name

system,network and communication,physiological monitors

510(k) Number K080192
Device Name HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS)
Applicant
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
55 northern blvd., suite 200
great neck, 
NY 
11021

Applicant Contact susan d goldstein
Correspondent
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
55 northern blvd., suite 200
great neck, 
NY 
11021

Correspodent Contact susan d goldstein
Regulation Number 870.2300
Classification Product Code
MSX  
Date Received 01/25/2008
Decision Date 04/03/2008
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