The following data is part of a premarket notification filed by Medfact Engineering Gmbh with the FDA for Easymap Map Catheter.
| Device ID | K151139 |
| 510k Number | K151139 |
| Device Name: | EasyMap MAP Catheter |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | MedFact Engineering GmbH Hammerstr.3 Loerrach, Baden-wurttemberg, DE D-79540 |
| Contact | Joerg Reinhardt |
| Correspondent | Melissa Walker Graematter, Inc 1324 Clarkson Clayton CTR, #332 Ballwin, MO 63011 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-29 |
| Decision Date | 2016-10-18 |