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SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE

K931963 Class I Traditional
Decision Date
1994-09-28
Sponsor / Applicant
Sandhill Scientific, Inc.

Technical Specification

510(k) Submission ID K931963
Product Code FFT
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.1400
Decision Date 1994-09-28
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE received FDA 510(k) clearance under submission number K931963, 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 1994-09-28.

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.