OUJ — High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist Class II
FDA product code OUJ covers "High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist", a Class II medical device regulated under 21 CFR 892.1570. Submissions are reviewed by the Radiology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OUJ
- Device Class
- Class II
- Regulation Number
- 892.1570
- Submission Type
- Review Panel
- HO
- Medical Specialty
- Radiology
- Implant
- No
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).