The following data is part of a premarket notification filed by Seamed Corp. with the FDA for Cpi Model 2215.
| Device ID | K923398 |
| 510k Number | K923398 |
| Device Name: | CPI MODEL 2215 |
| Classification | Pulse-generator, Pacemaker, External |
| Applicant | SEAMED CORP. 11810 NORTH CREEK PKWY. NORTH Bothell, WA 98011 |
| Contact | Marcia A Page |
| Correspondent | Marcia A Page SEAMED CORP. 11810 NORTH CREEK PKWY. NORTH Bothell, WA 98011 |
| Product Code | DTE |
| CFR Regulation Number | 870.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-10 |
| Decision Date | 1992-08-14 |