FDA product code PSW

High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid

Radiology·Class 2·21 CFR 892.1570
US regulatory classifications
US Product Code (FDA)
PSW
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 892.1570
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Medical specialty
Radiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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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About this record

High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid is a medical device type in the Radiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.