510(k) K002784
K002784 is an FDA 510(k) premarket notification submitted by Aloka Co., Ltd. for the device "ALOKA UST-5280-5". The FDA issued a decision of Substantially Equivalent on September 20, 2000. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Aloka Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 2000
- Date Received
- September 6, 2000
- Clearance Type
- Traditional
- 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