The following data is part of a premarket notification filed by Seamed Corp. with the FDA for Chronocor Vi Model 5012.
| Device ID | K915364 |
| 510k Number | K915364 |
| Device Name: | CHRONOCOR VI MODEL 5012 |
| Classification | Pulse-generator, Pacemaker, External |
| Applicant | SEAMED CORP. 11810 NORTH CREEK PKWY. NORTH Bothell, WA 98011 |
| Contact | Marcia Page |
| Correspondent | Marcia 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 | 1991-11-27 |
| Decision Date | 1992-02-07 |