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510(k) Data Aggregation
K Number
K003982Device Name
TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITOR
Manufacturer
MAGNETIC RESONANCE EQUIPMENT CORP.
Date Cleared
2001-01-26
(35 days)
Product Code
CCK
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
MAGNETIC RESONANCE EQUIPMENT CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K983250Device Name
INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR
Manufacturer
MAGNETIC RESONANCE EQUIPMENT CORP.
Date Cleared
1999-12-12
(452 days)
Product Code
DSK
Regulation Number
870.1110Why did this record match?
Applicant Name (Manufacturer) :
MAGNETIC RESONANCE EQUIPMENT CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Invasive blood pressure function is an option for the Model 9500 Multigas monitor. This function would be used when a clinician determined the need for continuous monitoring of arterial or venous blood pressure for adult patients undergoing MRI examination.
Device Description
The Invasive Blood Pressure function is an addition to a device legally marketed by MR Equipment Corporation. The device provides an additional measurement function to the Model 9500 Multigas Monitor. The existing 9500 monitor has pulse oximetry, ECG, non-invasive blood pressure (NIBP), capnograph and, optionally, oxygen and agent gas measurement functions. The Model 9500 is based on the BCI Model 9100 monitor with the same measuring functions, but the Model 9500 is specifically intended for use in the MR environment.
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K Number
K954120Device Name
MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR
Manufacturer
MAGNETIC RESONANCE EQUIPMENT CORP.
Date Cleared
1997-04-02
(579 days)
Product Code
CCK
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
MAGNETIC RESONANCE EQUIPMENT CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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