The following data is part of a premarket notification filed by American Technology, Inc. with the FDA for Endocardial Bipolar Lead.
| Device ID | K781456 |
| 510k Number | K781456 |
| Device Name: | ENDOCARDIAL BIPOLAR LEAD |
| Classification | Permanent Pacemaker Electrode |
| Applicant | AMERICAN TECHNOLOGY, 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 | 1978-08-23 |
| Decision Date | 1978-12-04 |