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

    IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006

    K Number: K992057 · Decision Sep 13, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    12
    Review Days
    87

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    Basic Information

    Device Name
    IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006
    K Number
    K992057
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sims Portex, Inc.
    Date Received
    June 18, 1999
    Decision Date
    September 13, 1999
    Product Code
    BTM
    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
    BTM Ventilator, Emergency, Manual (Resuscitator)

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    Other Clearances by Sims Portex, Inc.

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    K002201 ELECTROSTATIC HYDROPHOBIC BREATHING FILTER
    K002506 BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT
    K001318 CPAP SYSTEM, MODEL 102001
    K993619 CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK
    K994275 SIMS PORTEX ANESTHESIA CATHETER
    K991861 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE
    K992471 SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18
    K983858 SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES
    K981035 PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES
    Search all 12 clearances from Sims Portex, Inc. →