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

    MODEL DT-BAL, BALANCE SAVER

    K Number: K895323 · Decision Oct 24, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    25
    Applicant Total
    13
    Review Days
    56

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    Basic Information

    Device Name
    MODEL DT-BAL, BALANCE SAVER
    K Number
    K895323
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2700
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Spectramed, Inc.
    Date Received
    August 29, 1989
    Decision Date
    October 24, 1989
    Product Code
    KXO
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KXO Monitor, Pressure, Intrauterine

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    Other Clearances by Spectramed, Inc.

    K Number Device Name
    K896122 AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED
    K892941 CCO SYSTEM MODEL SP1467,SP5567,SP6267
    K894362 MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP
    K881857 AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.
    K885235 SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.
    K881825 MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH
    K875337 HEPARIN COATED LUMINAL PACING CATHETER
    K880740 MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE
    K873168 SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS
    K871573 CENTRAL VENOUS MULTI-LUMEN CATHETERS AND KITS
    Search all 13 clearances from Spectramed, Inc. →