PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR


Device Classification Name

oximeter

510(k) Number K072235
Device Name PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS 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 870.2700
Classification Product Code
DQA  
Date Received 08/10/2007
Decision Date 10/19/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls