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Found 6 results
510(k) Data Aggregation
K Number
K042705Device Name
DISPOSABLE NON-ADHESIVE SPO2 SENSORS
Manufacturer
ELEKON INDUSTRIES U.S.A., INC.
Date Cleared
2004-12-29
(90 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
ELEKON INDUSTRIES U.S.A., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in adult, pediatric, and neonatal patients.
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 adhesive film. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datexcompatible models.
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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?
Applicant Name (Manufacturer) :
ELEKON INDUSTRIES U.S.A., INC.
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
K042704Device Name
REUSABLE FINGER CLIP SPO2 SENSORS
Manufacturer
ELEKON INDUSTRIES U.S.A., INC.
Date Cleared
2004-11-26
(57 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
ELEKON INDUSTRIES U.S.A., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >20 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 rigid, spring-loaded clip. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datex-compatible models.
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K Number
K041522Device Name
FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS
Manufacturer
ELEKON INDUSTRIES U.S.A., INC.
Date Cleared
2004-09-14
(99 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
ELEKON INDUSTRIES U.S.A., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing ≥ 30 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 adhesive film. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datexcompatible models.
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K Number
K041647Device Name
FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE)
Manufacturer
ELEKON INDUSTRIES U.S.A., INC.
Date Cleared
2004-09-02
(77 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
ELEKON INDUSTRIES U.S.A., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring. The Flexi-Stat SpO2 Sensor is indicated for use in patients weighing >30 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 finger clip housing. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datex-compatible models.
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K Number
K041644Device Name
FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)
Manufacturer
ELEKON INDUSTRIES U.S.A., INC.
Date Cleared
2004-07-29
(42 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
ELEKON INDUSTRIES U.S.A., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in adult, pediatric, and neonatal patients.
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 foam and Velcro wrap. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datex-compatible models.
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