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Found 4 results
510(k) Data Aggregation
K Number
K042675Device Name
FLEXI-STAT SP02 EAR SENSOR
Manufacturer
ELEKON INDUSTRIES U.S.A., INC.
Date Cleared
2004-12-06
(68 days)
Product Code
DPZ
Regulation Number
870.2710Why did this record match?
Product Code :
DPZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >10 kg
Device Description
The Flexi-Stat(tm) SpO2 Sensor is an electro-optical sensor that functions 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 a durable ear clip housing. The sensor cable is terminated in a DB-9 style connector.
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K Number
K040831Device Name
DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
Manufacturer
DATEX-OHMEDA, INC.
Date Cleared
2004-09-02
(155 days)
Product Code
DPZ
Regulation Number
870.2710Why did this record match?
Product Code :
DPZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Datex-Ohmeda TruSat Pulse Oximeter and Accessories is indicated for spotchecking and continuous monitoring of functional oxygen saturation and pulse rate, including monitoring during conditions of clinical patient motion or low perfusion. These devices are intended for use with adult, pediatric and neonatal patients in both hospital and non-hospital environments.
Device Description
The TruSat is the next generation in the Datex-Ohmeda Pulse Oximeter family of products. The Datex-Ohmeda 3800 Series and 3900 Series Pulse Oximeters and Accessories with TruTrak Plus Enhancements and the Datex-Ohmeda TruSat Pulse Oximeter and Accessories are substantially equivalent in design concepts, technologies and materials. The TruSat was validated through rigorous testing that, in part, support the compliance of the TruSat to the above mentioned standards. Additionally, the software for the TruSat was developed following a robust software development process and was fully specified and validated.
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K Number
K012333Device Name
FLEXI-SITE SP02 EAR SENSOR
Manufacturer
EPIC MEDICAL EQUIPMENT SERVICES, INC.
Date Cleared
2001-10-17
(85 days)
Product Code
DPZ
Regulation Number
870.2710Why did this record match?
Product Code :
DPZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flexi-Site SpO2 Ear Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing > 30 kg.
Device Description
The Flexi-Site SpO2 Sensor is an electro-optical sensor that functions 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 a durable silicone casing. The sensor cable is terminated in a Hypertronics style connector.
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K Number
K010718Device Name
FLEXI-SITE SP02 EAR SENSOR
Manufacturer
EPIC MEDICAL EQUIPMENT SERVICES, INC.
Date Cleared
2001-03-23
(11 days)
Product Code
DPZ
Regulation Number
870.2710Why did this record match?
Product Code :
DPZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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