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

    GAS TRANSFILL

    K Number: K091191 · Decision Oct 23, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    286
    Applicant Total
    21
    Review Days
    183

    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
    GAS TRANSFILL
    K Number
    K091191
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5440
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Respironics Inc., Sleep & Home Respiratory Group
    Date Received
    April 23, 2009
    Decision Date
    October 23, 2009
    Product Code
    CAW
    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
    CAW Generator, Oxygen, Portable

    Similar 510(k) Clearances

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

    Portable Oxygen Concentrator

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Oxygen Concentrator (OX-5A, OX-5C)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OxyGo Portable Oxygen Concentrator (1400-7000)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DeVilbiss 5 Liter Oxygen Concentrator (555)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Oxygen Concentrator (J10A)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Oxygen Concentrator-P2-O5E

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

    Other Clearances by Respironics Inc., Sleep & Home Respiratory Group

    K Number Device Name
    K092835 COMFORTGEL NASAL MASK
    K092648 RESPIRONICS PERFORMAX SE TOTAL FACE MASK
    K090539 BIPAP AUTOSV ADVANCED
    K091843 COMFORT TWIN NASAL MASK
    K091066 COMFORT TWIN NASAL MASK
    K091319 REMSTAR AUTO A-FLEX
    K090484 ALICE PDX
    K091271 RESPIRONICS PERFORMAX TOTAL FACE MASK
    K090243 REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM
    K083526 TRILOGY 100 VENTILATOR
    Search all 21 clearances from Respironics Inc., Sleep & Home Respiratory Group →