The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Quantum(r) Models 253-19v & 254-20v Pulse Genera..
| Device ID | K874394 |
| 510k Number | K874394 |
| Device Name: | QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA. |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | INTERMEDICS, INC. P.O. BOX 617 Freeport, TX 77541 -0617 |
| Contact | Ken Bishop |
| Correspondent | Ken Bishop INTERMEDICS, INC. P.O. BOX 617 Freeport, TX 77541 -0617 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-28 |
| Decision Date | 1987-11-23 |