MASTERSCREEN & OXYCON CPX


Device Classification Name

calculator, pulmonary function data

510(k) Number K072323
Device Name MASTERSCREEN & OXYCON CPX
Applicant
VIASYS HEALTHCARE GMBH
22745 savi ranch pkwy.
yorba linda, 
CA 
92887

Applicant Contact yvette lloyd
Correspondent
VIASYS HEALTHCARE GMBH
22745 savi ranch pkwy.
yorba linda, 
CA 
92887

Correspodent Contact yvette lloyd
Regulation Number 868.1880
Classification Product Code
BZC  
Date Received 08/20/2007
Decision Date 10/10/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No