21 C.F.R. § 882.1925

Current through November 30, 2024
Section 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 .

21 C.F.R. §882.1925

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