The following data is part of a premarket notification filed by Seamed Corp. with the FDA for Seamed Model 3300 Dual Chamber Pacing System Analy.
| Device ID | K883930 |
| 510k Number | K883930 |
| Device Name: | SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY |
| Classification | Pulse-generator, Pacemaker, External |
| Applicant | SEAMED CORP. 11810 NORTH CREEK PKWY. NORTH Bothell, WA 98011 |
| Contact | Marcia A W.-page |
| Correspondent | Marcia A W.-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 | 1988-09-15 |
| Decision Date | 1988-11-09 |