510(k) K890284
K890284 is an FDA 510(k) premarket notification submitted by Ferguson Medical for the device "URODEC 500". The FDA issued a decision of Substantially Equivalent on May 30, 1989. The device falls under product code FES (Recorder, External, Pressure, Amplifier & Transducer), a Class II device regulated under 21 CFR 876.1725. Ferguson Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 1989
- Date Received
- January 19, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Recorder, External, Pressure, Amplifier & Transducer
- Device Class
- Class II
- Regulation Number
- 876.1725
- Review Panel
- GU
- Submission Type