The following data is part of a premarket notification filed by Electro-catheter Corp. with the FDA for Elecath Dual Mode Transthoracic Pacing.
| Device ID | K810312 |
| 510k Number | K810312 |
| Device Name: | ELECATH DUAL MODE TRANSTHORACIC PACING |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | ELECTRO-CATHETER CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-05 |
| Decision Date | 1981-03-04 |