The following data is part of a premarket notification filed by Ep Technologies, Inc. with the FDA for Steerocath(tm).
| Device ID | K900765 |
| 510k Number | K900765 |
| Device Name: | STEEROCATH(TM) |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | EP TECHNOLOGIES, INC. 897 INDEPENDENCE AVE. SUITE 1- D Mountain View, CA 94043 |
| Contact | S Cooperman |
| Correspondent | S Cooperman EP TECHNOLOGIES, INC. 897 INDEPENDENCE AVE. SUITE 1- D Mountain View, CA 94043 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-16 |
| Decision Date | 1990-05-07 |