Clearance Summary
FLEXI-STAT SP02 EAR SENSOR received FDA 510(k) clearance under submission number K042675, sponsored by Elekon Industries U.S.A., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-12-06.
- Submission: K042675
- Applicant / Sponsor: Elekon Industries U.S.A., Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2710
- Decision date: 2004-12-06
Classification & Regulation
This clearance is catalogued under FDA product code DPZ and 21 CFR 870.2710, within the Cardiovascular review panel as a Class II device.