The following data is part of a premarket notification filed by Seamed Corp. with the FDA for Seamed Model 3000.
| Device ID | K860462 |
| 510k Number | K860462 |
| Device Name: | SEAMED MODEL 3000 |
| Classification | Analyzer, Pacemaker Generator Function |
| Applicant | SEAMED CORP. 4500 - 150TH AVE. N.E. Redmond, WA 98052 |
| Contact | Daniel L Roper |
| Correspondent | Daniel L Roper SEAMED CORP. 4500 - 150TH AVE. N.E. Redmond, WA 98052 |
| Product Code | DTC |
| CFR Regulation Number | 870.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-06 |
| Decision Date | 1986-08-19 |