510(k) K081919
K081919 is an FDA 510(k) premarket notification submitted by Fukuda Denshi Co., Ltd. for the device "UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on Sep 9, 2008. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Fukuda Denshi Co., Ltd. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 9, 2008
- Date Received
- Jul 7, 2008
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- Yes
Device classification
- Device Name
- Transducer, Ultrasonic, Diagnostic
- Device Class
- Class II
- Regulation Number
- 892.1570
- Review Panel
- RA
- Submission Type
- 510(k)