Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K161245 |
Device Name |
EP-TRACER System |
Applicant |
CARDIO TEK, BV |
AMERIKALAAN 70 |
ae maastricht-airport limburg,
NL
6199
|
|
Applicant Contact |
OLIVER ROTH |
Correspondent |
GRAEMATTER, INC. |
1324 CLARKSON CLAYTON CENTER |
St Louis,
MO
63011
|
|
Correspondent Contact |
MELISSA WALKER |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 05/03/2016 |
Decision Date | 08/05/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|