The following data is part of a premarket notification filed by Multigon Industries, Inc. with the FDA for Model 600 Vascular Duplex Imager.
| Device ID | K863589 |
| 510k Number | K863589 |
| Device Name: | MODEL 600 VASCULAR DUPLEX IMAGER |
| Classification | Echocardiograph |
| Applicant | MULTIGON INDUSTRIES, INC. P.O. BOX 2485 Mt. Vernon, NY 10551 |
| Contact | William Stern |
| Correspondent | William Stern MULTIGON INDUSTRIES, INC. P.O. BOX 2485 Mt. Vernon, NY 10551 |
| Product Code | DXK |
| CFR Regulation Number | 870.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-15 |
| Decision Date | 1987-06-24 |