The following data is part of a premarket notification filed by Seamed Corp. with the FDA for Seamed Model 4000.
| Device ID | K854648 |
| 510k Number | K854648 |
| Device Name: | SEAMED MODEL 4000 |
| Classification | Pulse-generator, Pacemaker, External |
| Applicant | SEAMED CORP. 4500 - 150TH AVE. N.E. Redmond, WA 98052 |
| Contact | Dan Roper |
| Correspondent | Dan Roper SEAMED CORP. 4500 - 150TH AVE. N.E. Redmond, WA 98052 |
| Product Code | DTE |
| CFR Regulation Number | 870.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-19 |
| Decision Date | 1986-01-16 |