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K Number
K002028
Device Name
BRAVO PH MONITORING SYSTEM
Manufacturer
ENDONETICS, INC.
Date Cleared
2000-09-29

(88 days)

Product Code
FFT
Regulation Number
876.1400
Type
Traditional
Panel
Gastroenterology/Urology
Reference & Predicate Devices
N/A
Predicate For
K102543
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 876.1400 Stomach pH electrode.

(a)
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.(b)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.