510(k) K201488
K201488 is an FDA 510(k) premarket notification submitted by Micro-X , Ltd. for the device "Rover". The FDA issued a decision of Substantially Equivalent on Jul 17, 2020. 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
- Jul 17, 2020
- Date Received
- Jun 4, 2020
- Clearance Type
- Abbreviated
- 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)