The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Elox 45-bp, Model 330 132, Efh-27, Model 331 549, Extension Tool, Model 331 668.
| Device ID | K001413 |
| 510k Number | K001413 |
| Device Name: | ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668 |
| Classification | Permanent Pacemaker Electrode |
| Applicant | BIOTRONIK, INC. 6024 SW JEAN RD. B4 Lake Oswego, OR 97035 -3594 |
| Contact | Jon Brumbaugh |
| Correspondent | Jon Brumbaugh BIOTRONIK, INC. 6024 SW JEAN RD. B4 Lake Oswego, OR 97035 -3594 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-04 |
| Decision Date | 2000-06-02 |