510(k) K790365
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 1979
- Date Received
- February 22, 1979
- 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