ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1

• K Number: K010482
• Device Name: ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1
• Manufacturer: ECHOCATH, INC.
• Date Cleared: 2001-03-20 ( 28 days)
• Product Code: JOP
• Regulation Number: 870.2880
• Type: Special
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 870.2880 Ultrasonic transducer.

(a)
Identification. An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.(b)
Classification. Class II (performance standards).