Clearance Summary
SYMPHONY DEVICE received FDA 510(k) clearance under submission number DEN110011, sponsored by Sensory Medical, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2013-12-18.
- Submission: DEN110011
- Applicant / Sponsor: Sensory Medical, Inc.
- Clearance pathway: Post-NSE
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 882.5895
- Decision date: 2013-12-18
Classification & Regulation
This clearance is catalogued under FDA product code OVP and 21 CFR 882.5895, within the Physical Medicine review panel as a Class II device.