510(k) K113680
K113680 is an FDA 510(k) premarket notification submitted by Soma Access Systems, LLC for the device "SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT". The FDA issued a decision of Substantially Equivalent on December 29, 2011. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 2011
- Date Received
- December 15, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Imaging, Pulsed Echo, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- RA
- Submission Type