The following data is part of a premarket notification filed by Biotronik Sales, Inc. with the FDA for Biotronik Dfh Unipolar Pe-60/4-dfh.
| Device ID | K833106 |
| 510k Number | K833106 |
| Device Name: | BIOTRONIK DFH UNIPOLAR PE-60/4-DFH |
| Classification | Permanent Pacemaker Electrode |
| Applicant | BIOTRONIK SALES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-12 |
| Decision Date | 1983-10-20 |