BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MMI/GAELTEC SERIES 8T DIFF. PRESS. TRANS

    K Number: K801880 · Decision Aug 14, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    2
    Applicant Total
    8
    Review Days
    7

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    Basic Information

    Device Name
    MMI/GAELTEC SERIES 8T DIFF. PRESS. TRANS
    K Number
    K801880
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.2875
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Medical Measurements, Inc.
    Date Received
    August 7, 1980
    Decision Date
    August 14, 1980
    Product Code
    BYR
    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
    BYR Transducer, Gas Pressure, Differential

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    Other Clearances by Medical Measurements, Inc.

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    K863479 MODIFIED ICT/B INTRACRANIAL PRESS. TRANS. EPIDURAL
    K801757 MMI/GAELTEC CATHETER TIP PRESS. TRANSDU
    K801756 MMI/GAELTEC CATHETER TIP TRANSDUC
    K801758 MMI/GAELTEC CATHETER INTRAUTERINE
    K801755 MMI/GAELTEC CATHETER TIP PRESSURE