510(k) K123610
K123610 is an FDA 510(k) premarket notification submitted by Alpinion Medical Systems Co., Ltd. for the device "E-CUBE 15". The FDA issued a decision of Substantially Equivalent on Feb 1, 2013. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Alpinion Medical Systems Co., Ltd. has 25 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 1, 2013
- Date Received
- Nov 21, 2012
- Clearance Type
- Traditional
- 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
- 510(k)