Clearance Summary
SANDHILL SCIENTIFIC PEDIATEC PH PROBE received FDA 510(k) clearance under submission number K013951, sponsored by Sandhill Scientific, Inc.. 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 2002-02-28.
- Submission: K013951
- Applicant / Sponsor: Sandhill Scientific, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1400
- Decision date: 2002-02-28
Classification & Regulation
This clearance is catalogued under FDA product code FFT and 21 CFR 876.1400, within the Gastroenterology, Urology review panel as a Class I device.