← Product Code [FFT](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT) · K931963

# SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE (K931963)

_Sandhill Scientific, Inc. · FFT · Sep 28, 1994 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT/K931963

## Device Facts

- **Applicant:** Sandhill Scientific, Inc.
- **Product Code:** [FFT](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT.md)
- **Decision Date:** Sep 28, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1400
- **Device Class:** Class 1
- **Review Panel:** Gastroenterology, Urology

## Regulatory Identification

A stomach pH electrode is a device used to measure intragastric and intraesophageal pH (hydrogen ion concentration). The pH electrode is at the end of a flexible lead which may be inserted into the esophagus or stomach through the patient's mouth. The device may include an integral gastrointestinal tube.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT/K931963](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT/K931963)

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