The following data is part of a premarket notification filed by Cardiotek, B.v. with the FDA for Ep-tracer System, Ep-tracer System, Ep-tracer System.
| Device ID | K134044 |
| 510k Number | K134044 |
| Device Name: | EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | CARDIOTEK, B.V. 1324 CLARKSON CLAYTON CENTER #332 Ballwin, MO 6301 |
| Contact | Melissa Walker |
| Correspondent | Melissa Walker CARDIOTEK, B.V. 1324 CLARKSON CLAYTON CENTER #332 Ballwin, MO 6301 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-31 |
| Decision Date | 2014-03-31 |
| Summary: | summary |