Device Classification Name |
Calculator, Pulmonary Function Data
|
510(k) Number |
K150810 |
Device Name |
Vyntus / 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 | 868.1880
|
Classification Product Code |
|
Date Received | 03/26/2015 |
Decision Date | 08/14/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|