| Device Type ID | 1686 |
| Device Name | Urinometer, Electrical |
| Regulation Description | Urine Flow Or Volume Measuring System. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 876.1800 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | EXS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1686 |
| Device | Urinometer, Electrical |
| Product Code | EXS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urine Flow Or Volume Measuring System. |
| CFR Regulation Number | 876.1800 [🔎] |
| Device Problems | |
|---|---|
Volume Accuracy Problem | 6 |
Circuit Failure | 2 |
Device Dislodged Or Dislocated | 2 |
Inaccurate Flow Rate | 1 |
Erratic Or Intermittent Display | 1 |
Break | 1 |
Labelling, Instructions For Use Or Training Problem | 1 |
Calibration Problem | 1 |
Failure To Power Up | 1 |
| Total Device Problems | 16 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | C.R. Bard, Inc. | II | Jun-15-2018 |
| 2 | C.R. Bard, Inc. | II | Feb-09-2018 |
| 3 | C.R. Bard, Inc. | II | Jan-29-2018 |