TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR

K955018 · Instrumentarium Corp. · FFT · Jan 30, 1996 · Gastroenterology, Urology

Device Facts

Record IDK955018
Device NameTRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR
ApplicantInstrumentarium Corp.
Product CodeFFT · Gastroenterology, Urology
Decision DateJan 30, 1996
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 876.1400
Device ClassClass 1

Regulatory Classification

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.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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