510(k) K831788
K831788 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "URODYNAMIC ANALYZER". The FDA issued a decision of Substantially Equivalent on September 12, 1983. The device falls under product code FAN (Sigmoidoscope, Rigid, Electrical), a Class II device regulated under 21 CFR 876.1500. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 1983
- Date Received
- June 3, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sigmoidoscope, Rigid, Electrical
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type