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

    UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550)

    K Number: K970046 · Decision Mar 28, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    195
    Registration Numbers
    195
    Same Product Code
    0
    Applicant Total
    5
    Review Days
    81

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    Basic Information

    Device Name
    UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550)
    K Number
    K970046
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5590
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Accutron, Inc.
    Date Received
    January 6, 1997
    Decision Date
    March 28, 1997
    Product Code
    KHA
    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
    KHA Mask, Scavenging

    Other Clearances by Accutron, Inc.

    K Number Device Name
    K052335 ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA
    K033503 RFS VACUUM GAUGE SCAVENGING CIRCUIT
    K992421 GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076
    K965239 PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U)