BIOSENSOR BIDOP VASCULAR TEST SYSTEM

• K Number: K943338
• Device Name: BIOSENSOR BIDOP VASCULAR TEST SYSTEM
• Manufacturer: BIOSENSOR CORP.
• Date Cleared: 1996-04-12 ( 640 days)
• Product Code: JAF
• Regulation Number: 892.1540

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 892.1540 Nonfetal ultrasonic monitor.

(a)
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.(b)
Classification. Class II.

Summary

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