Device Type ID | 1979 |
Device Name | Table, Cystometric, Non-electric And Accessories |
Regulation Description | Urological Table And Accessories. |
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) Renal Devices Branch (RNDB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 876.4890 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | KQS |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1979 |
Device | Table, Cystometric, Non-electric And Accessories |
Product Code | KQS |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Urological Table And Accessories. |
CFR Regulation Number | 876.4890 [🔎] |