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

    HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION

    K Number: K934190 · Decision Nov 24, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    72
    Applicant Total
    7
    Review Days
    90

    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
    HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION
    K Number
    K934190
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bird Life Design
    Date Received
    August 26, 1993
    Decision Date
    November 24, 1993
    Product Code
    BYD
    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
    BYD Condenser, Heat And Moisture (Artificial Nose)

    Similar 510(k) Clearances

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

    HEAT & MOISTURE EXCHANGER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    DISPOSABLE HME/FILTER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    HEAT MOISTURE EXCHANGER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    TYPE 1 & 2 (HUMIDAIR I & II)

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology
    View all

    Other Clearances by Bird Life Design

    K Number Device Name
    K931487 BLD HEATED BREATHING CIRCUIT W/EXHALATION VALVE
    K934189 BARRIERFLEX-I, AND BARRIERFLES-II
    K934540 BARRIERFLEX-PF PULMONARY FUNCTION TESTING FILTER
    K933641 BLD NEONATAL HEATED WIRE BREATHING CIRCUIT- 30 VOLT COMPATIBLE
    K925543 BLD-18000 SERIES HEATED BREATHING CIRCUIT
    K930252 BABYSET AND PAC (PULMONARY ASSIST CIRCUIT)