The following data is part of a premarket notification filed by Seamed Corp. with the FDA for Cpi Model 2215/seamed Model 3400.
| Device ID | K910223 |
| 510k Number | K910223 |
| Device Name: | CPI MODEL 2215/SEAMED MODEL 3400 |
| Classification | Analyzer, Pacemaker Generator Function |
| Applicant | SEAMED CORP. 11810 NORTH CREEK PKWY. NORTH Bothell, WA 98011 |
| Contact | Keith Payea |
| Correspondent | Keith Payea SEAMED CORP. 11810 NORTH CREEK PKWY. NORTH Bothell, WA 98011 |
| Product Code | DTC |
| CFR Regulation Number | 870.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-18 |
| Decision Date | 1991-03-19 |