U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 28, 2025
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All TitlesTitle 21Chapter IPart 880Subpart G - Subpart G—General Hospital and Personal Use Miscellaneous Devices
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(a) Identification. An ultrasonic cleaner for medical instruments is a device intended for cleaning medical instruments by the emission of high frequency soundwaves.
(b) Classification. Class I. The device, including any solutions intended for use with the device for cleaning and sanitizing the instruments, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.
