Clearance Summary
BITESTRIP received FDA 510(k) clearance under submission number K030869, sponsored by S.L.P. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2004-05-14.
- Submission: K030869
- Applicant / Sponsor: S.L.P. , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1375
- Decision date: 2004-05-14
Classification & Regulation
This clearance is catalogued under FDA product code KZM and 21 CFR 890.1375, within the Physical Medicine review panel as a Class II device.