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Found 4 results
510(k) Data Aggregation
K Number
K081335Device Name
TENACORE OXYGEN BLENDER, MODEL TB-2000
Manufacturer
TENACORE HOLDINGS, INC.
Date Cleared
2008-11-14
(186 days)
Product Code
BZR
Regulation Number
868.5330Why did this record match?
Applicant Name (Manufacturer) :
TENACORE HOLDINGS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tenacore Oxygen Blender, is intended for non-invasive mixing and delivery of a ratio of therapeutic oxygen and medical grade air as a stand-alone unit or as a component of a respiratory support apparatus.
Device Description
The Tenacore Oxygen Blender is typically a wall-mounted unit that provides inlets for medical grade air and therapeutic oxygen. The percentage of oxygen to air can be adjusted from 21-100%.
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K Number
K053420Device Name
TENACORE SP02 SENSORS
Manufacturer
TENACORE HOLDINGS, INC.
Date Cleared
2006-11-15
(342 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
TENACORE HOLDINGS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Accessory to pulse oximeter for the purpose of continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.
Device Description
SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in soft pad with a clear window. The sensor cable is terminated in a connector that couples with the corresponding monitor.
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K Number
K043075Device Name
TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
Manufacturer
TENACORE HOLDINGS, INC.
Date Cleared
2005-08-18
(283 days)
Product Code
HGM
Regulation Number
884.2740Why did this record match?
Applicant Name (Manufacturer) :
TENACORE HOLDINGS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These transducers are intended to be used as replacement accessories for Hewlett Packard and Corometrics fetal monitors. These transducers measure fetal heart rate or uterine contractions in the gravid patient.
Device Description
Tenacore Holdings, Inc. Transducers for Fetal Ultrasound and Tokodynamometer Monitoring are direct replacements for similar transducers manufactured by GE Marquette Medical Systems and Epic Medical Equipment Services. A Transducer employing ultrasound Doppler Shift Technology is used for the detection of Fetal Heart Rate during labor and a Tokodynamometer Transducer, which actually is a strain gauge, is used to evaluate and measure the duration, frequency, and relative pressure of uterine contractions during labor.
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K Number
K012041Device Name
THE HAMMER MODEL H100
Manufacturer
TENACORE HOLDINGS, INC.
Date Cleared
2002-03-28
(272 days)
Product Code
DXC
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
TENACORE HOLDINGS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated in the compression of the femoral artery or vein after catherization.
Device Description
Not Found
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