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High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist

FDA product code OUJ · 4 cleared devices

Class 2 Radiology
Regulation
21 CFR 892.1570
Review panel
HO
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2011-02-24 – 2025-08-05

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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