The following data is part of a premarket notification filed by Cardio Tek, Bv with the FDA for Ep-tracer System.
| Device ID | K161245 |
| 510k Number | K161245 |
| Device Name: | EP-TRACER System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | CARDIO TEK, BV AMERIKALAAN 70 Ae Maastricht-airport Limburg, NL 6199 |
| Contact | Oliver Roth |
| Correspondent | Melissa Walker GRAEMATTER, INC. 1324 CLARKSON CLAYTON CENTER St Louis, MO 63011 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-03 |
| Decision Date | 2016-08-05 |
| Summary: | summary |