The following data is part of a premarket notification filed by Schwarzer Cardiotek Gmbh with the FDA for Ep-tracer System.
| Device ID | K183266 |
| 510k Number | K183266 |
| Device Name: | EP-TRACER System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Schwarzer CardioTek GmbH Im Zukunftspark 3 Heilbronn, DE 74076 |
| Contact | Tatjana Nuber |
| Correspondent | Melissa Walker Graematter, Inc. 1324 Clarkson Clayton Ctr, #332 Ballwin, MO 63011 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-23 |
| Decision Date | 2019-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260441455418 | K183266 | 000 |
| 04260441450574 | K183266 | 000 |
| 04260441450482 | K183266 | 000 |
| 04260441455425 | K183266 | 000 |
| 04260441455326 | K183266 | 000 |