The following data is part of a premarket notification filed by Coratomic, Inc. with the FDA for Coratomic #vx5-105 & Vx5-205 Pulse Gen..
| Device ID | K822791 |
| 510k Number | K822791 |
| Device Name: | CORATOMIC #VX5-105 & VX5-205 PULSE GEN. |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | CORATOMIC, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-15 |
| Decision Date | 1982-12-15 |