Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K162023 |
Device Name |
CardioDay V2.5 |
Applicant |
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
ODERSTR. 77 |
TELTOW,
DE
14513
|
|
Applicant Contact |
BERT SCHADOW |
Correspondent |
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
ODERSTR. 77 |
TELTOW,
DE
14513
|
|
Correspondent Contact |
BERT SCHADOW |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 07/22/2016 |
Decision Date | 03/24/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|