Device Type ID | 1996 |
Device Name | Table, Cystometric, Electric |
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) Urology And Lithotripsy Devices Branch (ULDB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 876.4890 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | MMZ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1996 |
Device | Table, Cystometric, Electric |
Product Code | MMZ |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Urological Table And Accessories. |
CFR Regulation Number | 876.4890 [🔎] |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Sonesta Medical Ab | II | Apr-28-2017 |