High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist
Medical specialty
Radiology
Device class
2
Regulation number
892.1570
Review panel
HO
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Ineligible
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).