| Device Type ID | 1727 |
| Device Name | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Regulation Description | Urodynamics Measurement 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 | 876.1620 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FAP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1727 |
| Device | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Product Code | FAP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urodynamics Measurement System. |
| CFR Regulation Number | 876.1620 [🔎] |
| Device Problems | |
|---|---|
Device Contaminated During Manufacture Or Shipping | 1 |
Material Rupture | 1 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Teleflex Medical Europe Ltd | II | Apr-12-2018 |