Search Results
Found 3 results
510(k) Data Aggregation
K Number
K964804Device Name
FLEXILOG LS
Manufacturer
Date Cleared
1997-08-06
(250 days)
Product Code
Regulation Number
876.1725Why did this record match?
Applicant Name (Manufacturer) :
OAKFIELD INSTRUMENTS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FLEXILOG LS is used for the location of the lower and/or upper esophageal sphincter and the measuring of the nares to esophageal sphincter distance. This procedure being carried out prior to the accurate placement of a pH sensitive catheter for an ambulatory pH study to quantify gastroesophageal reflux.
The FLEXILOG LS, Esophagea1 Sphinctor Locator, is to be used for the manometric location of the lower and upper esophageal sphincters. That is the measurement of the distance from the nares to the sphincter.
Device Description
The FLEXILOG LS is a single channel, pressure monitoring system comprising of a module of electronics that provides transducer excitation, amplification and transmission of the signal to a computer via an optically isolated RS232 connector. The pressure signal is displayed on the computer VDU via a Microsoft Windows display program. The program does not provide any analysis or data saving options.
The electronics module is designed to be compatible with catheter tip perfused pressure transducers currently available in the US market.
Ask a Question
Ask a specific question about this device
K Number
K964589Device Name
FLEXILOG 3000
Manufacturer
Date Cleared
1997-03-04
(109 days)
Product Code
Regulation Number
876.1725Why did this record match?
Applicant Name (Manufacturer) :
OAKFIELD INSTRUMENTS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FLEXILOG 3000 system is to be used for the recording, display and analysis of pH and pressure data from the upper gastrointestinal tract in ambulant subjects. It provides information that aids in the diagnosis and management of motility disorders. The FLEXILOG 3000 also has a limited stationary manometry capability to aid sensor placement prior to an ambulatory study.
Device Description
The FLEXILOG 3000 system is a multi channel, multi parameter, ambulatory recording system with stationary capability. It is comprised of a recorder that supports data collection on up to 24 channels. The data collected is determined by up to 5 plug-in parameter modules. At present only pH (4 channel) and pressure (3 channel) modules are available. Multiple modules of the parameters can be installed to give the required number of channels. In ambulatory mode, data is saved onto a PCMCIA card and subsequently uploaded to the computer. In stationary mode, data is transferred via a patient isolated RS232 outlet to the computers serial port. The signals, recorded or online, are displayed on the computer VDU via a Microsoft Windows based program, FLEXISOFT III. FLEXISOFT III provides display, analysis and report generation options. The FLEXILOG 3000 is compatible with pressure and pH catheters currently approved for sale in the U.S.A. and manufactured and marketed by third parties.
Ask a Question
Ask a specific question about this device
K Number
K961895Device Name
FLEXILOG LS 13921
Manufacturer
Date Cleared
1996-11-04
(172 days)
Product Code
Regulation Number
876.1725Why did this record match?
Applicant Name (Manufacturer) :
OAKFIELD INSTRUMENTS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FLEXILOG LS is used for the location of the lower esophageal sphincter and the measuring of the nares to lower esophageal sphincter distance. This procedure being carried out prior to the accurate placement of a pH sensitive catheter for an ambulatory pH study to quantify gastroesophageal reflux.
Device Description
The FLEXILOG LS is a single channel, pressure monitoring system comprising of a module of electronics that provides transducer excitation, amplification and transmission of the signal to a computer via an optically isolated RS232 connector. The pressure signal is displayed on the computer VDU via a Microsoft Windows display program. The program does not provide any analysis or data saving options. The electronics module is designed to be compatible with catheter tip and water perfused pressure transducers currently available in the US market.
Ask a Question
Ask a specific question about this device
Page 1 of 1