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

    CARESCAPE R860

    K Number: K210384 · Decision Nov 4, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    58
    Review Days
    268

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    Basic Information

    Device Name
    CARESCAPE R860
    K Number
    K210384
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Datex-Ohmeda, Inc.
    Date Received
    February 9, 2021
    Decision Date
    November 4, 2021
    Product Code
    CBK
    Advisory Committee
    Anesthesiology
    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
    CBK Ventilator, Continuous, Facility Use

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    Other Clearances by Datex-Ohmeda, Inc.

    K Number Device Name
    K251663 Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)
    K213867 Carestation 750/750c
    K172702 Tec 820, Tec 850
    K172045 Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2
    K170872 Aisys CS2
    K151570 Carestation 620/650/650C
    K142679 CARESCAPE R860
    K143530 Aespire View
    K140575 ENGSTROM CARESTATION, ENGSTROM PRO
    K132530 GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)
    Search all 58 clearances from Datex-Ohmeda, Inc. →