SHAPEABLE DOPPLER FLOW PROBE

K002958 · Cook Vascular, Inc. · ITX · Dec 18, 2001 · Radiology

Device Facts

• Record ID: K002958
• Device Name: SHAPEABLE DOPPLER FLOW PROBE
• Applicant: Cook Vascular, Inc.
• Product Code: ITX · Radiology
• Decision Date: Dec 18, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.