The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Elox P 45-bp; Elox P 53-bp; Elox P 60-bp.
| Device ID | K023205 |
| 510k Number | K023205 |
| Device Name: | ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP |
| Classification | Permanent Pacemaker Electrode |
| Applicant | BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Contact | Jon Brumbaugh |
| Correspondent | Jon Brumbaugh BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-25 |
| Decision Date | 2003-04-24 |
| Summary: | summary |