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

    LIFE PULSE RESUSCITATION TIMER

    K Number: K932867 · Decision Jul 25, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    1
    Applicant Total
    5
    Review Days
    406

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    Basic Information

    Device Name
    LIFE PULSE RESUSCITATION TIMER
    K Number
    K932867
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.5210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Green Field Medical Sourcing, Inc.
    Date Received
    June 14, 1993
    Decision Date
    July 25, 1994
    Product Code
    PMK
    Advisory Committee
    Cardiovascular
    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
    PMK Cpr Aid Device Without Feedback

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PMK), ordered by most recent decision date.

    LIFE PULSE TESUSCITATION TIMER

    FDA 510(k)
    FDA Class 1 ·Cardiovascular
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    Other Clearances by Green Field Medical Sourcing, Inc.

    K Number Device Name
    K971759 MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER
    K971348 FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM
    K954150 VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
    K944667 LIFE PULSE TESUSCITATION TIMER