Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K183266 |
Device Name |
EP-TRACER System |
Applicant |
Schwarzer CardioTek GmbH |
Im Zukunftspark 3 |
Heilbronn,
DE
74076
|
|
Applicant Contact |
Tatjana Nuber |
Correspondent |
Graematter, Inc. |
1324 Clarkson Clayton Ctr, #332 |
Ballwin,
MO
63011
|
|
Correspondent Contact |
Melissa Walker |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 11/23/2018 |
Decision Date | 03/01/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|