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
|
|
Correspondent Contact |
THOMAS RUST |
Regulation Number | 868.1890
|
Classification Product Code |
|
Subsequent Product Code |
|
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
|
|
|