510(k) K130308
K130308 is an FDA 510(k) premarket notification submitted by Hitachi Aloka Medical, Ltd. for the device "NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM". The FDA issued a decision of Substantially Equivalent on April 5, 2013. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Hitachi Aloka Medical, Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 2013
- Date Received
- February 7, 2013
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1550
- Review Panel
- RA
- Submission Type