510(k) K211423
K211423 is an FDA 510(k) premarket notification submitted by Micro-X Limited for the device "Rover". The FDA issued a decision of Substantially Equivalent on May 21, 2021. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 2021
- Date Received
- May 7, 2021
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1720
- Review Panel
- RA
- Submission Type
- 510(k)