21 CFR 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.

[ 44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38807, July 25, 2001]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code