510(k) K142329
K142329 is an FDA 510(k) premarket notification submitted by Dbmedx, Inc. for the device "BBS REVOLUTION". The FDA issued a decision of Substantially Equivalent on Dec 15, 2014. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 15, 2014
- Date Received
- Aug 20, 2014
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Imaging, Pulsed Echo, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- RA
- Submission Type
- 510(k)