510(k) K130902
K130902 is an FDA 510(k) premarket notification submitted by Syntermed, Inc. for the device "EMORY CARDIAC TOOLBOX 3.2". The FDA issued a decision of Substantially Equivalent on Jun 14, 2013. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Syntermed, Inc. has 13 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 14, 2013
- Date Received
- Apr 1, 2013
- Clearance Type
- Traditional
- 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)