The following data is part of a premarket notification filed by Seamed Corp. with the FDA for Seamed, #540 - Siemens, #146f Telectro.
| Device ID | K820570 |
| 510k Number | K820570 |
| Device Name: | SEAMED, #540 - SIEMENS, #146F TELECTRO |
| Classification | Pulse-generator, Pacemaker, External |
| Applicant | SEAMED CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DTE |
| CFR Regulation Number | 870.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-02 |
| Decision Date | 1982-06-03 |