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

    SIMS INTERTECH HYPERINFLATION BAG SYSTEM

    K Number: K952214 · Decision Jun 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    9
    Applicant Total
    29
    Review Days
    28

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    Basic Information

    Device Name
    SIMS INTERTECH HYPERINFLATION BAG SYSTEM
    K Number
    K952214
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Intertech Resources, Inc.
    Date Received
    May 11, 1995
    Decision Date
    June 8, 1995
    Product Code
    NHK
    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
    NHK Resuscitator, Manual, Non Self-Inflating

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    Other Clearances by Intertech Resources, Inc.

    K Number Device Name
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    K952223 XENON GAS BREATHING CIRCUIT
    K952062 PFT FILTER
    K952169 SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC
    K935036 HEPA FILTERED HEAT AND MOISTURE EXCHANGER
    K930816 HEPA FILTERED HME
    K922479 DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED
    K921624 DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS
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