21 CFR 892.1540 — Monitor, Ultrasonic, Nonfetal

Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1540

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.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
JAFMonitor, Ultrasonic, Nonfetal2383rd Party
Innolitics

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