Clearance Summary
H&S-CONDUCTIVITY STANDARD SOLUTION received FDA 510(k) clearance under submission number K041636, sponsored by H & S Technical Services. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2004-07-02.
- Submission: K041636
- Applicant / Sponsor: H & S Technical Services
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2004-07-02
Classification & Regulation
This clearance is catalogued under FDA product code FKH and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.