Title 21: Food and Drugs
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/ PART 882 - NEUROLOGICAL DEVICES
/ Subpart B - Neurological Diagnostic Devices / § 882.1925 Ultrasonic scanner calibration test block.
§ 882.1925 Ultrasonic scanner calibration test block.
(a) Identification. An ultrasonic scanner calibration test block is a block of material with known properties used to calibrate ultrasonic scanning devices (e.g., the echoencephalograph).
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.