Clearance Summary
SMARTWAND-DTX received FDA 510(k) clearance under submission number K093557, sponsored by Clearcount Medical Solutions. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2009-12-18.
- Submission: K093557
- Applicant / Sponsor: Clearcount Medical Solutions
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.2740
- Decision date: 2009-12-18
Classification & Regulation
This clearance is catalogued under FDA product code LWH and 21 CFR 880.2740, within the General Hospital review panel as a Class I device.