510(k) K143232
K143232 is an FDA 510(k) premarket notification submitted by Meridian Medical Systems, LLC for the device "Universal Digital Interface 2W, UDI 2W". The FDA issued a decision of Substantially Equivalent on January 30, 2015. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. Meridian Medical Systems, LLC has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2015
- Date Received
- November 10, 2014
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type