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

    CUFF-CATH

    K Number: K935090 · Decision Oct 14, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    120
    Review Days
    357

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    Basic Information

    Device Name
    CUFF-CATH
    K Number
    K935090
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ohmeda Medical
    Date Received
    October 22, 1993
    Decision Date
    October 14, 1994
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Ohmeda Medical

    K Number Device Name
    K123309 GIRAFFE AND PANDA WARMERS
    K101788 GIRAFFE OMNIBED
    K101778 GIRAFFE INCUBATOR
    K090697 MODIFICATION TO: GIRAFFE AND PANDA WARMER
    K072157 MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
    K070377 GIRAFFE AND PANDA WARMER
    K070210 GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
    K070247 GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
    K040068 BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
    K020543 OHMEDA MEDICAL GIRAFFE OMNIBED
    Search all 120 clearances from Ohmeda Medical →