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510(k) Data Aggregation
K Number
K102801Device Name
PHTIP DISPOSABLE ISFET CATHETER
Manufacturer
Date Cleared
2010-10-26
(29 days)
Product Code
Regulation Number
876.1725Why did this record match?
Applicant Name (Manufacturer) :
E-CATH CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The pHTip™ Disposable ISFET Catheter is a device used to measure intragastric and intraesophageal pH activity in the stomach or esophagus, by means of a flexible lead with ISFET pH electrodes that is introduced through the nose into the gastrointestinal tract. It is intended especially for gastro esophageal testing for the severity of acid reflux events. The device may include conductive rings for impedance studies, and may also include signal conditioning and amplifying equipment.
Device Description
The pHTIP Disposable ISFET Catheter is a device used to measure pH activity in the stomach or esophagus by means of a probe with transducers, which is introduced through the nose into the gastrointestinal tract, and is intended especially for gastro esophageal testing for the severity of acid reflux events. The device may include conductive rings for impedance studies, and may also include signal conditioning and amplifying equipment.
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