510(k) K111021
K111021 is an FDA 510(k) premarket notification submitted by Mcube Technology Co., Ltd. for the device "CUBESCAN / BIOCON-700". The FDA issued a decision of Substantially Equivalent on Apr 27, 2011. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Mcube Technology Co., Ltd. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 27, 2011
- Date Received
- Apr 12, 2011
- 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
- 510(k)