BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR

    K Number: K090438 · Decision Jul 24, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    9
    Review Days
    154

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    Basic Information

    Device Name
    REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR
    K Number
    K090438
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Envitec-Wismar GmbH
    Date Received
    February 20, 2009
    Decision Date
    July 24, 2009
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DQA Oximeter

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    Other Clearances by Envitec-Wismar GmbH

    K Number Device Name
    K133064 MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31
    K122290 ENVITEC MYSIGN O OXYGEN MEASURING DEVICE
    K102270 ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN
    K082655 ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106
    K070193 ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES
    K060675 ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS
    K043463 ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS
    K992215 MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED