FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT


Device Classification Name

calculator, predicted values, pulmonary function

510(k) Number K080734
Device Name FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT
Applicant
VIASYS HEALTHCARE GMBH
leibnizstrasse 7
hoechberg, 

DE

97204

Applicant Contact thomas rust
Correspondent
VIASYS HEALTHCARE GMBH
leibnizstrasse 7
hoechberg, 

DE

97204

Correspodent Contact thomas rust
Regulation Number 868.1890
Classification Product Code
BTY  
Subsequent Product Code
DPS  
Date Received 03/14/2008
Decision Date 06/26/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No