PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1


Device Classification Name

oximeter

510(k) Number K111617
Device Name PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1
Applicant
ACARE TECHNOLOGY CO., LTD.
p.o. box 237-023
shanghai, 

CN

200237

Applicant Contact diana hong
Correspondent
ACARE TECHNOLOGY CO., LTD.
p.o. box 237-023
shanghai, 

CN

200237

Correspodent Contact diana hong
Regulation Number 870.2700
Classification Product Code
DQA  
Date Received 06/10/2011
Decision Date 12/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No