510(k) K223422
K223422 is an FDA 510(k) premarket notification submitted by Syntermed for the device "Emory Cardiac Toolbox 4.3". The FDA issued a decision of Substantially Equivalent on Mar 30, 2023. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Syntermed has 13 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 30, 2023
- Date Received
- Nov 14, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Tomography, Computed, Emission
- Device Class
- Class II
- Regulation Number
- 892.1200
- Review Panel
- RA
- Submission Type
- 510(k)