| Device Type ID | 2541 |
| Device Name | Cleaner, Ultrasonic, Medical Instrument |
| Regulation Description | Ultrasonic Cleaner For Medical Instruments. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Infection Control Devices Branch (INCB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.6150 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FLG |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2541 |
| Device | Cleaner, Ultrasonic, Medical Instrument |
| Product Code | FLG |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Ultrasonic Cleaner For Medical Instruments. |
| CFR Regulation Number | 880.6150 [🔎] |
| Device Problems | |
|---|---|
Thermal Decomposition Of Device | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Solder Joint Fracture | 2 |
Device Operates Differently Than Expected | 2 |
Unintended Electrical Shock | 1 |
Circuit Failure | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Loss Of Or Failure To Bond | 1 |
Disconnection | 1 |
| Total Device Problems | 13 |