510(k) K831788
- Device
- Urodynamic Analyzer
- Applicant
- C.R. BARD, INC.
- 510(k) number
- K831788
- Product code
- FAN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-09-12
- Date received
- 1983-06-03
- Regulation
- 876.1500
- Classification name
- Sigmoidoscope, Rigid, Electrical
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3038293255
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FAN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232262 | LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 ) | Surgease Innovations Limited | 2023-11-30 |