510(k) K811925
K811925 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "UROFLOWMETER". The FDA issued a decision of Substantially Equivalent on September 8, 1981. The device falls under product code FFG (Device, Urine Flow Rate Measuring, Non-Electrical, Disposable), a Class II device regulated under 21 CFR 876.1800. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 1981
- Date Received
- July 2, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
- Device Class
- Class II
- Regulation Number
- 876.1800
- Review Panel
- GU
- Submission Type