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High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid

FDA product code PSW · 6 cleared devices

Class 2 Radiology
Regulation
21 CFR 892.1570
Review panel
HO
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2005-08-18 – 2023-11-21

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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