Clearance Summary
SPSMEDICAL SPORVIEW PLUS STEAM BI TEST PACK received FDA 510(k) clearance under submission number K051173, sponsored by Spsmedical Supply Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2005-05-27.
- Submission: K051173
- Applicant / Sponsor: Spsmedical Supply Corp.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 2005-05-27
Classification & Regulation
This clearance is catalogued under FDA product code FRC and 21 CFR 880.2800, within the General Hospital review panel as a Class II device.