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Found 11 results
510(k) Data Aggregation
K Number
K014269Device Name
POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102
Manufacturer
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
Date Cleared
2002-11-21
(329 days)
Product Code
MYE
Regulation Number
876.1735Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PolygrafID with POLYGRAM NET™ ElectroGastroGraphy Application is intended to record, store, process and view gastric myoelectrical activity as an aid in the diagnosis of gastrointestinal motility disorders.
Device Description
The system is a stationary electrogastrography system for use in the evaluation of gastrointestinal motility disorders. The system measures the myoelectrical activity of the gastrum using sensors situated on the skin. The parameters measured are presented on a computer screen during the capture and are also stored for later display, review, analysis and reporting.
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K Number
K011471Device Name
BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER
Manufacturer
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
Date Cleared
2002-11-08
(543 days)
Product Code
FFX
Regulation Number
876.1725Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Polygram 98 pH Testing System is intended to record, store, view and analyze esophageal and gastric refluxate data to diagnose reflux disorders. The Polygram 98 pH Testing 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 system is an ambulatory system for use in evaluating reflux disorders in the gastrointestinal tract. The system measures bile online using sensors in the patient. The data is captured and recorded. The data is uploaded from the Bilitec 2000 by use of the Polygram 98 pH Testing Application software for later display, analysis and reporting. In its daily use, a trained technician and/or physician are the main user of the system.
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K Number
K002992Device Name
DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431
Manufacturer
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
Date Cleared
2001-08-15
(324 days)
Product Code
IKT, FMI, GXZ
Regulation Number
890.1385Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K011472Device Name
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID
Manufacturer
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
Date Cleared
2001-08-10
(88 days)
Product Code
FFX
Regulation Number
876.1725Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K010130Device Name
POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103
Manufacturer
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
Date Cleared
2001-02-07
(22 days)
Product Code
FFX
Regulation Number
876.1725Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000386Device Name
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111
Manufacturer
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
Date Cleared
2000-05-05
(88 days)
Product Code
FFX
Regulation Number
876.1725Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992715Device Name
NEURO URODYNAMIC SUITE, MODEL 9032E0101
Manufacturer
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
Date Cleared
2000-02-28
(200 days)
Product Code
FEN, GWF, JXE
Regulation Number
876.1620Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Neuro-Urodynamics Suite for Duet / Duet MultiP is indicated for electrophysiological testing of the pelvic organs including motor nerve conduction, sacral reflex, and free-run EMG tests.
Device Description
The Duet version 8.1 is enhanced with a new suite of test programs for EMG and Motor Nerve conduction measurements. The suite is called Neuro Urodynamics Suite and consists of the following predefined testprogram:
- Neuro Free Run EMG
- Neuro Motor Nerve Conduction
- Neuro Sacral Reflex
The Neuro Urodynamic Suite is together with Duet MultiP intended to record a patients urodynamic functions and examination of the motor innervation of the spincters and the pelvic floor and the sensory innervation of pelvic structures.
The whole system includes transducers, devices, tubing, catheters and electrodes. The tests are operated just like the urodynamic and anorectal tests. A license number is required to enable the software for the Neuro Urodynamic Suite.
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K Number
K992713Device Name
POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101
Manufacturer
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
Date Cleared
1999-11-10
(90 days)
Product Code
FFX
Regulation Number
876.1725Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Esophageal Manometry System is intended to record, store, view and analyze data on line in the gastrointestinal tract to assist in the diagnoses of gastrointestinal disorders.
Device Description
The system is a stationary manometry system for use in evaluating the function of the gastrointestinal tract. The system measures pressure and other parameters online using sensors on and in the patient. The parameters are presented during the capture and are also recorded for later display, analysis and reporting.
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K Number
K991389Device Name
ANORECTAL MANOMETRY SUITE, MODEL 9032S0201
Manufacturer
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
Date Cleared
1999-07-15
(85 days)
Product Code
FFX
Regulation Number
876.1725Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Duet-with Anorectal Manometry Suite is intended to measure and record the functioning of the patient's urinary tract and anorectal function*. The measurements comprise recording of pressure, volume, flow and EMG. The system includes transducers, devices, tubing, catheters and electrodes. * expanded indication for use due to the Anorectal Manometry Suite.
Device Description
The Anorectal Manometry Suit is together with Duet/Duet MultiP intended to record a patients anorectal function compromising EMG and pressure recordings. The whole system includes transducers, devices, tubing, catheters and electrodes. The Duet / Duet MultiP is an apparatus capable of registration of pressure signals over a long time. The measurements and analysis have originally been developed for urodynamics tests, but since anorectal tests also are measuring pressure signals over a period of time, it is suitable to use the same technique for these types of tests, i.e. anorectal tests. The device is used in a dedicated clinical setup. The following sets of test types are predefined tests for measuring in the rectum: Sphincter Profile, Resting Pressure, Rectal Balloon test, Balloon Expulsion Test, Squeeze Test, Recto-Anal Inhibitory Test. The tests are operated just like the urodynamic tests. A license number is required to enable the software for the Anorectal Manometry Suite.
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K Number
K990375Device Name
DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75
Manufacturer
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
Date Cleared
1999-03-09
(29 days)
Product Code
IKT
Regulation Number
890.1385Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Monopolar Needles Electrodes are used for recording unit potentials in skeletal muscles, spontaneous activity, interference patterns and conduction velocity studies. This process is known as electromyography (EMG).
Device Description
The disposable monopolar needle electrode is designed for single use only. The stainless steel needle electrode is insulated with a special PTFE coating to ensure minimal friction between the needle and the tissue. The tip of the conically sharpened needle is uninsulated and serves as recording area. The sterile electrode is individually sealed and delivered in sets of 48 pcs. In a hygienic and practical package ready for use package. The electrodes consists of a PTFE coated needle with an exposed area in the tip. The PTFE coating eases insertion into tissue and isolates the needle electrical. There are two diameters of the needles. In the non-invasive end of the device there is attached a connector, which enables the electrical signal to be transferred to the cable.
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