Device Classification Name |
Calculator, Predicted Values, Pulmonary Function
|
510(k) Number |
K122699 |
Device Name |
SENTRYSUITE PRODUCT LINE |
Applicant |
CAREFUSION GERMANY 234 GMBH |
LEIBNIZSTRASSE 7 |
HOECHBERG,
DE
97204
|
|
Applicant Contact |
ELMAR NIEDERMEYER |
Correspondent |
CAREFUSION GERMANY 234 GMBH |
LEIBNIZSTRASSE 7 |
HOECHBERG,
DE
97204
|
|
Correspondent Contact |
ELMAR NIEDERMEYER |
Regulation Number | 868.1890
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/04/2012 |
Decision Date | 11/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|