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510(k) Data Aggregation
K Number
K980980Device Name
MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50
Manufacturer
KONIGSBERG INSTRUMENTS, INC.
Date Cleared
1998-06-15
(90 days)
Product Code
FFX
Regulation Number
876.1725Why did this record match?
Applicant Name (Manufacturer) :
KONIGSBERG INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kongsberg Instruments Inc. Motility Probe is manufactured for use in the evaluation and diagnosis of gastrum lerological dysfunction related to muscir tonus and the coundination of contractions between muscle groups. The Motility frobe provides several types of information with may be used in these diagnoses. Primary among these is pressure information at multiple sensor sites. Secondary to the pressure information is the ability of the probe to measure pH in the Stomach and esophagus. This can reveal the presence of gastric reflux from the stomach into the esophair.
Device Description
Motility Probes: models P31-P38, P40-P43, and P50
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