The following data is part of a premarket notification filed by Vascular Technology Incorporated with the FDA for Vti 20 Mhz Gated Doppler.
| Device ID | K031091 |
| 510k Number | K031091 |
| Device Name: | VTI 20 MHZ GATED DOPPLER |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | VASCULAR TECHNOLOGY INCORPORATED 175 CABOT ST. Lowell, MA 01854 |
| Contact | David L Regan |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-04-07 |
| Decision Date | 2003-04-23 |