510(k) K212830
- Device
- CT3000Pro
- Applicant
- Srs Medical
- 510(k) number
- K212830
- Product code
- FEN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-12-21
- Date received
- 2021-09-07
- Regulation
- 876.1620
- Classification name
- Device, Cystometric, Hydraulic
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Lee Brody
- Address
- 76 Treble Cove Rd. Bldg. 3 North Billerica MA US 01862 01862
FDA Registration Numbers#
- 1223851
- 3010170586
- 1720929
- 3034424132
- 1526863
- 3004134316
- 9611896
- 3013885240
- 9615942
- 9616567
- 3011987967
- 1313046
- 3004967767
- 3034630389
- 1216677
- 3006174295
- 1450662
- 3012480535
- 1224842
- 2246552
- 3017448360
- 1223490
- 3012174468
- 3010400865
- 3002806603
- 3006617533
- 9611590
- 3004207966
- 3035451914
- 3007611554
- 3000296634
- 3004111573
- 1825146
- 3018383108
- 3004727093
- 3008132398
- 3008806809
- 3011790297
- 3013223546
- 3043503763
- 3005941719
- 1722684
- 3016854619
- 3009746061
- 1820334
- 3012307300
- 1647149
- 3006082230
- 3011137372
- 1319639
- 1018233
- 9617192
- 2032098
- 3010041511
- 3004365956
- 3004729999
Source Documents#
Other 510(k) Records For Product Code FEN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K082701 | URONIRS, MODEL 2000 | Urodynamix Technologies, Ltd. | 2008-12-18 |
| K073552 | LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY | Laborie Medical Technologies, Corp. | 2008-03-05 |
| K001386 | ACCUSET SENSOR, MODEL 2000 | Pelvicare, Inc. | 2000-07-17 |
| K992715 | NEURO URODYNAMIC SUITE, MODEL 9032E0101 | Medtronic Functional Diagnostics A/S | 2000-02-28 |
| K983325 | IN-PROBE II URODYNAMIC SYSTEM | Influence, Inc. | 1998-11-24 |
| K970595 | CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP | Circon Video | 1997-10-24 |
| K971911 | LUMAX CYSTOMETRY ADMINISTRATION TUBE SET | Medamicus, Inc. | 1997-06-03 |
| K964522 | ELLIPSE 4 | Andromeda Medizinische Systeme GmbH | 1997-03-21 |
| K960503 | DANTEC DUET | Dantec Medical, Inc. | 1996-09-16 |
| K953734 | LUMAX(MODIFICATION) | Medamicus, Inc. | 1996-01-18 |
| K954093 | LUMAX (MODIFICATION) | Medamicus, Inc. | 1996-01-11 |
| K954315 | PVC ABDOMINAL/RECTAL PRESSURE CATHETER | Life-Tech Intl., Inc. | 1995-11-30 |
| K954341 | URODYNAMICS TUBING AND INFUSION SETS | Life-Tech Intl., Inc. | 1995-10-17 |
| K953451 | UROPUMP TUBE & DAMPING CHAMGER | Life-Tech Intl., Inc. | 1995-10-05 |
| K953353 | UROVISION JANUS | Life-Tech Intl., Inc. | 1995-09-08 |