FLOSCOPE SUPER VASCULAR LAB
Device Facts
| Record ID | K943200 |
|---|---|
| Device Name | FLOSCOPE SUPER VASCULAR LAB |
| Applicant | Advance Medical Device, Inc. |
| Product Code | JAF · Radiology |
| Decision Date | Nov 21, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1540 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
