The following data is part of a premarket notification filed by Seamed Corp. with the FDA for Telectronics Model 2401.
| Device ID | K831697 |
| 510k Number | K831697 |
| Device Name: | TELECTRONICS MODEL 2401 |
| Classification | Analyzer, Pacemaker Generator Function |
| Applicant | SEAMED CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DTC |
| CFR Regulation Number | 870.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-25 |
| Decision Date | 1984-09-04 |