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Found 6 results
510(k) Data Aggregation
K Number
K983680Device Name
TRINITY II SINGLE CHAMBER DVT PUMP
Manufacturer
DELPHI CONSULTING GROUP
Date Cleared
1999-04-28
(190 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
DELPHI CONSULTING GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trinity II Single Chamber DVT System Pump (with sleeves), is designed to reduce pooling of blood, increase venous blood flow in the lower extremities of the recumbent patient to reduce deep vein thrombosis and pulmonary embolism. The intended patient population is adult with the environment of use being hospital, clinic.
Device Description
The Trinity II Single Chamber DVT Pump is a device designed to reduce pooling of blood and increase venous blood flow in the lower extremities of recumbent patients. It uses compressible limb sleeves.
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K Number
K963957Device Name
TRINITY DVT SYSTEM
Manufacturer
DELPHI CONSULTING GROUP
Date Cleared
1997-11-04
(398 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
DELPHI CONSULTING GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trinity DVT System is designed to reduce pooling of blood, increase venous blood flow in the lower extremities of the recumbent patient to reduce deep vein thrombosis and pulmonary embolism.
Device Description
Compressible Limb Sleeve and Pump, Single Chamber
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K Number
K970014Device Name
TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.)
Manufacturer
DELPHI CONSULTING GROUP
Date Cleared
1997-08-06
(216 days)
Product Code
JOW, 74J
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
DELPHI CONSULTING GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trinity Huntleigh Pump Compatible Sleeves is designed to reduce pooling of blood, increase venous blood flow in the lower extremities of the recumbent patient to reduce deep vein thrombosis and pulmonary embolism.
Device Description
Compressible Limb Sleeves
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K Number
K961937Device Name
SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM
Manufacturer
DELPHI CONSULTING GROUP
Date Cleared
1996-12-09
(203 days)
Product Code
DQD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
DELPHI CONSULTING GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SimulScope® Bedside Auscultation System allows the user to amplify heart, lung and bowel sounds and transmit them via infrared energy to wireless headphone worn by more then one listener. The system uses an electronic stethoscope connected to a transmitter unit and a receiving unit(s) for each listener.
Device Description
The SimulScope® Bedside Auscultation System allows the user to amplify heart, lung and bowel sounds and transmit them via infrared energy to wireless headphone worn by more then one listener. The system uses an electronic stethoscope connected to a transmitter unit and a receiving unit(s) for each listener.
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K Number
K961301Device Name
E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-7120
Manufacturer
DELPHI CONSULTING GROUP
Date Cleared
1996-06-11
(68 days)
Product Code
DQD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
DELPHI CONSULTING GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K954489Device Name
TRINITY SLEEVE(S)
Manufacturer
DELPHI CONSULTING GROUP
Date Cleared
1996-02-22
(148 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
DELPHI CONSULTING GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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