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510(k) Data Aggregation
K Number
K020365Device Name
3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE
Manufacturer
3T MEDICAL SYSTEMS, LLC.
Date Cleared
2002-05-03
(88 days)
Product Code
KRI
Regulation Number
870.4200Why did this record match?
Product Code :
KRI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3T Myocardial Needle Temperature Probes are indicated for use in the routine monitoring of temperature during open-heart surgery and is intended for insertion into the myocardium.
Device Description
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K Number
K992635Device Name
INTERFACE MODULE IDDD
Manufacturer
STOECKERT INSTRUMENTE
Date Cleared
1999-12-20
(136 days)
Product Code
KRI, DTQ
Regulation Number
870.4200Why did this record match?
Product Code :
KRI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Stöckert S3 heart lung machine and the SC heart lung system are integrated heart lung machines for cardiopulmonary bypass. The Interface Module IDDD provides serial data output from the Stöckert S3 and SC Heart Lung Machines for recording on an external PC or other recording devices. Serial output information from external devices like blood gas analyzers or patient monitors can also be input to the Interface Module IDDD to be passed through to the serial output. The output protocol provides a complete overview of all relevant data obtained from the heart lung machine as well as from external devices. The serial output data are intended for procedure documentation, and are not intended for making clinical decisions for diagnosis.
Device Description
The Stöckert Interface Module IDDD is an addition to the Stöckert S3 heart lung machine (K950990) and the SC heart lung system (K982014), which were both previously cleared for marketing. The Interface Module IDDD provides serial data output from the Stöckert S3 and SC Heart Lung Machines for recording data on an external PC or other recording devices. Serial output information from external devices like blood gas analyzers or patient monitors can also be input to the Interface Module IDDD to be passed through to the serial output. The Interface Module IDDD is installed into the Electronics and Power Supply Pack (E/P) of the S3 or the Sensor Module Rack of the SC. A CAN bus system manages the data transfer.
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K Number
K990512Device Name
STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS
Manufacturer
STOECKERT INSTRUMENTE
Date Cleared
1999-11-23
(278 days)
Product Code
KRI
Regulation Number
870.4200Why did this record match?
Product Code :
KRI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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