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 |