510(k) K182281
K182281 is an FDA 510(k) premarket notification submitted by C. R. Bard for the device "Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech". The FDA issued a decision of Substantially Equivalent on October 24, 2018. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. C. R. Bard has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 24, 2018
- Date Received
- August 23, 2018
- Clearance Type
- Traditional
- 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