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510(k) Data Aggregation

    K Number
    K012333
    Device Name
    FLEXI-SITE SP02 EAR SENSOR
    Manufacturer
    EPIC MEDICAL EQUIPMENT SERVICES, INC.
    Date Cleared
    2001-10-17

    (85 days)

    Product Code
    DPZ
    Regulation Number
    870.2710
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPIC MEDICAL EQUIPMENT SERVICES, INC.

    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
    K002848
    Device Name
    SPO2 WRAP SENSOR
    Manufacturer
    EPIC MEDICAL EQUIPMENT SERVICES, INC.
    Date Cleared
    2001-05-24

    (253 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPIC MEDICAL EQUIPMENT SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010718
    Device Name
    FLEXI-SITE SP02 EAR SENSOR
    Manufacturer
    EPIC MEDICAL EQUIPMENT SERVICES, INC.
    Date Cleared
    2001-03-23

    (11 days)

    Product Code
    DPZ
    Regulation Number
    870.2710
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPIC MEDICAL EQUIPMENT SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002223
    Device Name
    EPIC SPO2 FINGER SENSOR, MODEL E412-20
    Manufacturer
    EPIC MEDICAL EQUIPMENT SERVICES, INC.
    Date Cleared
    2000-08-22

    (29 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPIC MEDICAL EQUIPMENT SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000831
    Device Name
    STAT-SHELL DISPOSABLE SP02 SENSOR
    Manufacturer
    EPIC MEDICAL EQUIPMENT SERVICES, INC.
    Date Cleared
    2000-06-05

    (83 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPIC MEDICAL EQUIPMENT SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992811
    Device Name
    TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
    Manufacturer
    EPIC MEDICAL EQUIPMENT SERVICES, INC.
    Date Cleared
    2000-01-18

    (151 days)

    Product Code
    HFM
    Regulation Number
    884.2720
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPIC MEDICAL EQUIPMENT SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These devices are intended for use as replacement accessories to Corometrics and Hewlett Packard Monitors, to measure fetal heart rate and uterine contractions in the gravid patient.
    Device Description
    Epic's ultrasound and tocodynamometer (toco) transducers are replacements for similar transducers manufactured by Corometrics and Hewlett Packard for their respective monitors. The ultrasound transducers are used to detect the fetal heart rate using Doppler shift technology and the toco transducers detect uterine activity using a strain gauge for evaluating the fetal heart rate during a contraction. These transducers are intended to be a direct replacement for the OEM transducers.
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    K Number
    K992092
    Device Name
    STAT-SHELL DISPOSABLE SPO2 SENSOR
    Manufacturer
    EPIC MEDICAL EQUIPMENT SERVICES, INC.
    Date Cleared
    1999-12-22

    (184 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPIC MEDICAL EQUIPMENT SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stat-Shell Disposable SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring for patients weighing more than 30 kg. It is intended for single patient reuse.
    Device Description
    The Stat-Shell SpO2 Disposable Sensor is an electro-optical sensor which functions without skin penetration, electrical contact, or heat transfer. It is an accessory to compatible SpO2 oximeters. 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 photodiode is housed in a textured, rigid shell that is contoured for patient digit placement. The LED's are housed in a foam tape that is positioned over the nail bed and wrapped around the patient's digit. The sensor cable is 2 feet in length and is terminated in a DB-9 style connector. An adapter cable extends the length and converts the connector to a Hypertronics style.
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    K Number
    K992211
    Device Name
    SPO2 WRAP SENSOR
    Manufacturer
    EPIC MEDICAL EQUIPMENT SERVICES, INC.
    Date Cleared
    1999-12-22

    (174 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPIC MEDICAL EQUIPMENT SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SpO2 Wrap Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring for patients weighing more than 30 kg.
    Device Description
    The SpO2 Wrap Sensor is an electro-optical sensor which functions without skin penetration, electrical contact, or heat transfer. It is an accessory to compatible SpO2 oximeters. 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 LED's and photodiode are contained in a flexible, L-shaped housing that is positioned over the desired patient digit and secured in place with a fabric wrap. The sensor cable is 3-12 feet in length and is terminated in DB-9 and Hypertronics style connectors.
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    K Number
    K990082
    Device Name
    EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09
    Manufacturer
    EPIC MEDICAL EQUIPMENT SERVICES, INC.
    Date Cleared
    1999-04-09

    (88 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPIC MEDICAL EQUIPMENT SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Reusable sensor for continuous non-invasive functional arterial oxygen saturation and pulse rate monitoring for patients weighing more than 30 kg. with the Datex Satlite and AS/3 monitors.
    Device Description
    The Epic Medical Equipment Services. Inc. E403-09 SpO2Finger Sensor is a reusable clip-on finger sensor with the optical components, protected in a hard plastic case. It functions without skin penetration, electrical contact, or heat transfer. This electrooptical sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The E403-09 Finger 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 E403-09 is three feet in length and is terminated in a DB9 style connector as is the predicate sensor. The E403-09 is used with E710-09 10 foot cable which both extends the length of the E403-09 as well as adapts the DB9 connector to a Nicolay style connector which connects to the oximeter. The E412-09 is equivalent to the E403-09 (3 foot) plus E710-09 (10 foot). The E412-09 is 12 feet long and terminates with a Nicolay style connector.
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    K Number
    K970098
    Device Name
    E100 SERIES SPO2 SENSORS
    Manufacturer
    EPIC MEDICAL EQUIPMENT SERVICES, INC.
    Date Cleared
    1998-04-30

    (472 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPIC MEDICAL EQUIPMENT SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Reusable finger sensor for continuous non-invasive arterial oxygen saturation and pulse rate monitoring with the following oximeters: Ohmeda, Novametrix 500, Novametrix Superbright, Spacelabs oximeter module, Criticare, BCI, Datascope.
    Device Description
    Reusable finger sensor for continuous non-invasive arterial oxygen saturation and pulse rate monitoring.
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