510(k) K761083
K761083 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD URINE METER W/ BAG". The FDA issued a decision of Substantially Equivalent on January 26, 1977. The device falls under product code EXR (Urinometer, Mechanical), 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
- January 26, 1977
- Date Received
- November 19, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Urinometer, Mechanical
- Device Class
- Class II
- Regulation Number
- 876.1800
- Review Panel
- GU
- Submission Type