510(k) K192590
K192590 is an FDA 510(k) premarket notification submitted by Fmi Medical Systems, Inc. for the device "CURA 778". The FDA issued a decision of Substantially Equivalent on Mar 5, 2020. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Fmi Medical Systems, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 5, 2020
- Date Received
- Sep 20, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Tomography, Computed
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type
- 510(k)