510(k) K212654
K212654 is an FDA 510(k) premarket notification submitted by Oxos Medical, Inc. for the device "Micro C Medical Imaging System, M01". The FDA issued a decision of Substantially Equivalent on February 4, 2022. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Oxos Medical, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 2022
- Date Received
- August 23, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, X-Ray, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1720
- Review Panel
- RA
- Submission Type