BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer

    K Number: K170663 · Decision May 11, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    1
    Review Days
    431

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
    K Number
    K170663
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Foremount Enterprise Co., Ltd.
    Date Received
    March 6, 2017
    Decision Date
    May 11, 2018
    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)

    Similar 510(k) Clearances

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

    The BAG manual resuscitator and accessories

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    butterflyBVM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EOlife®

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Sotair Device

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Disposable Manual Resuscitator

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all