OUJ

4 FDA 510(k) clearances · Product code

FDA profile

Official device name

High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist

Device class

Class II (moderate risk)

Regulation

21 CFR 892.1570

Medical specialty

Radiology

Flags

Third-party review eligible

FDA definition

To provide high level disinfection of ultrasound transducers. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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