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 Http
| Device Type ID | 2803 |
| Device Name | High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist |
| Physical State | Ultrasonic Transducer Reprocessor, High Level Disinfectant Mist, And Accessories |
| Technical Method | Automatically Generates A Mist From A Dedicated Hydrogen Peroxide Disinfectant Solution And Exposes A Suspended Ultrasound Transducer To The Disinfectant Mist At A Specified Temperature And For A Specified Time To Achieve High Level Disinfection |
| Target Area | Ultrasonic Transducers |
| Regulation Description | Diagnostic Ultrasonic Transducer. |
| Regulation Medical Specialty | Radiology |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 892.1570 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OUJ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2803 |
| Device | High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist |
| Product Code | OUJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Diagnostic Ultrasonic Transducer. |
| CFR Regulation Number | 892.1570 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
NANOSONICS LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |