510(k) K905369
K905369 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Information Technologies for the device "UST-2266U-5 CW DOPPLER TRANSDUCER". The FDA issued a decision of Substantially Equivalent on February 11, 1991. The device falls under product code JOP (Transducer, Ultrasonic), a Class II device regulated under 21 CFR 870.2880. Ge Medical Systems Information Technologies has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 11, 1991
- Date Received
- November 29, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 870.2880
- Review Panel
- CV
- Submission Type