The following data is part of a premarket notification filed by Ep Technologies, Inc. with the FDA for Tracfinder Ii.
| Device ID | K924108 |
| 510k Number | K924108 |
| Device Name: | TRACFINDER II |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | EP TECHNOLOGIES, INC. 350 POTRERO AVE. Sunnyvale, CA 94086 |
| Contact | Gary A Seeger |
| Correspondent | Gary A Seeger EP TECHNOLOGIES, INC. 350 POTRERO AVE. Sunnyvale, CA 94086 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-14 |
| Decision Date | 1993-12-16 |