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Found 4 results
510(k) Data Aggregation
K Number
K102543Device Name
BRAVO PH MONITORING SYSTEM AND ACCESSORIES
Manufacturer
GIVEN IMAGING LTD.
Date Cleared
2010-12-01
(89 days)
Product Code
FFT
Regulation Number
876.1400Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data.
Device Description
The Bravo pH Monitoring System™ and Accessories is an ambulatory esophageal pH testing device. The Bravo system is a simple, minimally invasive outpatient procedure that involves the placement of a pH telemetry Capsule against the mucosal wall of the esophagus that simultaneously measures pH and transmits the data to a receiver attached to the patient's waist. The Bravo pH Monitoring System™ and Accessories consists of four main components: Bravo pH Capsule with Delivery System, Bravo pH Receiver, RAPID pH and PolygramNet software, and Bravo pH Delivery System Accessories.
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K Number
K013951Device Name
SANDHILL SCIENTIFIC PEDIATEC PH PROBE
Manufacturer
SANDHILL SCIENTIFIC, INC.
Date Cleared
2002-02-28
(90 days)
Product Code
FFT
Regulation Number
876.1400Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used to measure intragastric and intraesophageal pH (hydrogen ion concentration) in pediatric patients
Device Description
Not Found
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K Number
K981733Device Name
DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111
Manufacturer
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
Date Cleared
1999-02-04
(262 days)
Product Code
FFX
Regulation Number
876.1725Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The pH System is intended to record, store, view and analyze esophageal and gastric pH data to diagnose reflux disorders. The pH System can also be used to locate the position of the proximal Lower Esophageal Sphincter (LES) manometrically, to assist in the accurate placement of the pH catheter.
Device Description
The pH Testing System consists of a general purpose PC running the pH Application software namned EsopHogram '98, a recording device namned Digitrapper Delta and catheters appropriate for the study to be performed. The illustration below shows the various components.
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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?
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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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