PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA


Device Classification Name

oximeter

510(k) Number K103685
Device Name PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA
Applicant
BEIJING RONGRUI-CENTURY SCIE. & TECH. CO., LTD.
p.o. box 237-023
shangahi, 

CN

200237

Applicant Contact diana hong
Correspondent
BEIJING RONGRUI-CENTURY SCIE. & TECH. CO., LTD.
p.o. box 237-023
shangahi, 

CN

200237

Correspodent Contact diana hong
Regulation Number 870.2700
Classification Product Code
DQA  
Date Received 12/17/2010
Decision Date 07/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No