The following data is part of a premarket notification filed by Biotronik Sales, Inc. with the FDA for Dnr Unipolar.
| Device ID | K853568 |
| 510k Number | K853568 |
| Device Name: | DNR UNIPOLAR |
| Classification | Permanent Pacemaker Electrode |
| Applicant | BIOTRONIK SALES, INC. POST OFFICE BOX 1988 Lake Oswego, OR 97034 |
| Contact | Juergen M Bahr |
| Correspondent | Juergen M Bahr BIOTRONIK SALES, INC. POST OFFICE BOX 1988 Lake Oswego, OR 97034 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-26 |
| Decision Date | 1986-01-15 |