Rover
FDA 510(k) clearance K211423 · decided 2021-05-21
Clearance details
- K-number
- K211423
- Device name
- Rover
- Applicant
- Micro-X Limited
- Decision
- Substantially Equivalent
- Date received
- 2021-05-07
- Decision date
- 2021-05-21
- Days to decision
- 14 days
- Clearance type
- Special
- Product code
- IZL
- Device class
- 2
- Regulation number
- 892.1720
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Cloverly Park, AU
- Third-party review
- No
- Expedited review
- No
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