Device Classification Name |
oximeter
|
510(k) Number |
K142959 |
Device Name |
Vyntus Walk |
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 | 870.2700
|
Classification Product Code |
|
Date Received | 10/14/2014 |
Decision Date | 03/20/2015 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|