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Found 7 results
510(k) Data Aggregation
K Number
K121014Device Name
SOLAR GI
Manufacturer
MEDICAL MEASUREMENT SYSTEMS,B.V.
Date Cleared
2012-08-01
(120 days)
Product Code
FFX
Regulation Number
876.1725Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL MEASUREMENT SYSTEMS,B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MPP Plus is an accessory device to be used with the MMS Solar GI system for intraluminal studies of the gastro-intestinal tract (Pharynx, esophagus, stomach, duodenum, Sphincter of Oddi, small bowel, colon, and anorectal area including rectum) to perfuse demineralized or distilled water through the lumen of a multi-lumen catheter to measure pressures.
The perfusion pump can also be used for automated balloon filling (for anorectal manometry studies). The filling lumen of the catheter can be connected to the perfusion pump.
Designated catheters and accessories are required for measurement in each specific area.
Device Description
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K Number
K071094Device Name
MODIFICATION TO SOLAR GI
Manufacturer
MEDICAL MEASUREMENT SYSTEMS,B.V.
Date Cleared
2007-08-13
(117 days)
Product Code
FFX
Regulation Number
876.1725Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL MEASUREMENT SYSTEMS,B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Solar Perfusion Pump is an accessory device to be used with the MMS Solar GI system for intraluminal studies of the gastro-intestinal tract (Pharynx, esophagus, stomach, duodenum, Sphincter of Oddi, small bowel, colon, and anorectal area including rectum) to perfuse demineralized or distilled water through the lumen of a multi-lumen catheter to measure pressures. Designated catheters and accessories are required for measurement in each specific area.
Device Description
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K Number
K060166Device Name
OHMEGA
Manufacturer
MEDICAL MEASUREMENT SYSTEMS,B.V.
Date Cleared
2006-04-21
(88 days)
Product Code
FFX
Regulation Number
876.1725Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL MEASUREMENT SYSTEMS,B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ohmega system is intended to record, store, view and analyse pH, impedance, pressure and various auxiliary input data in the gastrointestinal tract (pharynx, esophagus, stomach, duodenum, sphincter of oddi, small bowel, colon and anorectal area including rectum and pelvic floor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders.
Designated catheters and accessories are required for measurement in each specific area.
Device Description
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K Number
K052338Device Name
SOLAR GI
Manufacturer
MEDICAL MEASUREMENT SYSTEMS,B.V.
Date Cleared
2005-12-15
(111 days)
Product Code
FFX
Regulation Number
876.1725Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL MEASUREMENT SYSTEMS,B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Solar GI system is intended to record, store, view and analyse pressure, EMG, swallow and respiration and various auxiliary input device data on-line anywhere in the gastrointestinal tract (pharynx, esophagus, stomach, duodenum, sphincter of oddi, small bowel, colon and anorectal area including rectum and pelvic floor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Designated catheters and accessories are required for measurement in each specific area.
Device Description
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K Number
K050993Device Name
MMS VIDEO OPTION
Manufacturer
MEDICAL MEASUREMENT SYSTEMS,B.V.
Date Cleared
2005-05-26
(37 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL MEASUREMENT SYSTEMS,B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MMS Video option is intended to acquire, view, record, process, print, archive and retrieve video images such as of gastroenterology and urology procedures.
Device Description
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K Number
K031084Device Name
SOLAR GI SYSTEM
Manufacturer
MEDICAL MEASUREMENT SYSTEMS,B.V.
Date Cleared
2004-03-19
(350 days)
Product Code
FFX
Regulation Number
876.1725Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL MEASUREMENT SYSTEMS,B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Solar GI system is intended to record, store, view and analyse pressure, EMG, swallow and respiration and various auxiliary input device data on-line anywhere in the gastrointestinal tract (pharynx, esophagus, stomach, duodenum, sphirycter of oddi, small bowel, colon and anorectal area including rectum and pelvic flor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Designated catheters and accessories are required for measurement in each specific area.
Device Description
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K Number
K031930Device Name
HIGH SPEED EMG MODULE
Manufacturer
MEDICAL MEASUREMENT SYSTEMS,B.V.
Date Cleared
2004-03-03
(254 days)
Product Code
GWF, FEN, JXE
Regulation Number
882.1870Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL MEASUREMENT SYSTEMS,B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Solar Neuro Module is indicated for electro-physiological testing of the pelvic organs including motor nerve conduction, sacral reflex and free-run EMG tests.
Device Description
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