PORTABLE OXYGEN UNIT SCA900


Device Classification Name

regulator, pressure, gas cylinder

510(k) Number K080243
Device Name PORTABLE OXYGEN UNIT SCA900
Applicant
SAN CHEONG CO. LTD.
13340 e firestone blvd
suite j
santa fe springs, 
CA 
90670

Applicant Contact jung bae bang
Correspondent
SAN CHEONG CO. LTD.
13340 e firestone blvd
suite j
santa fe springs, 
CA 
90670

Correspodent Contact jung bae bang
Regulation Number 868.2700
Classification Product Code
CAN  
Subsequent Product Code
ECX  
Date Received 01/31/2008
Decision Date 04/07/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No