Device Classification Name |
electrocardiograph
|
510(k) Number |
K170182 |
Device Name |
CARDIOVIT FT-1 |
Applicant |
SCHILLER AG |
ALTGASSE 68 |
baar,
CH
ch-6371
|
|
Applicant Contact |
zhenrong yu |
Correspondent |
ZOE MEDICAL, INC |
460 BOSTON STREET |
topsfield,
MA
01983
|
|
Correspondent Contact |
jim chickering |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 01/23/2017 |
Decision Date | 07/19/2017 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|