The following data is part of a premarket notification filed by Seamed Corp. with the FDA for External Pacemaker Telectronics Te200.
| Device ID | K852746 |
| 510k Number | K852746 |
| Device Name: | EXTERNAL PACEMAKER TELECTRONICS TE200 |
| Classification | Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) |
| Applicant | SEAMED CORP. 4500 - 150TH AVE. N.E. Redmond, WA 98052 |
| Contact | William L Scott |
| Correspondent | William L Scott SEAMED CORP. 4500 - 150TH AVE. N.E. Redmond, WA 98052 |
| Product Code | JOQ |
| CFR Regulation Number | 870.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-27 |
| Decision Date | 1985-09-12 |