510(k) K231283
K231283 is an FDA 510(k) premarket notification submitted by Bard Access Systems, Inc. (C.R. Bard, Inc.) for the device "SiteRite 9 Ultrasound System". The FDA issued a decision of Substantially Equivalent on Sep 11, 2023. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Bard Access Systems, Inc. (C.R. Bard, Inc.) has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 11, 2023
- Date Received
- May 3, 2023
- 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