LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K042727
    Device Name
    POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A
    Manufacturer
    FOREMOUNT ENT. CO., LTD.
    Date Cleared
    2005-03-18

    (168 days)

    Product Code
    CBP
    Regulation Number
    868.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOREMOUNT ENT. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Foremount Pocket Size Resuscitator / Model M16201R is indicated for use of The Foremount Pocket oize Nesubonator Amedel with non-rebreathing valve for adult and child whose weight exceeds 10kg. The resuscitator with oxygen port is for prescription use. The Foremount Pocket Size Resuscitator / Model M16201A is indicated for use of ter and The Foremount Pocket Size Resulsciator / Model MTF22 MTF mouth to mask ventilation via the ventilation mask with non-rebreathing valve for adult . In mask ventilation via the and child whose weight exceeds 10kg. and child whose worgen oxygen port is for over-the-counter use.
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1