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

    BABYSET AND PAC (PULMONARY ASSIST CIRCUIT)

    K Number: K930252 · Decision Feb 9, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    199
    Registration Numbers
    199
    Same Product Code
    183
    Applicant Total
    7
    Review Days
    32

    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
    BABYSET AND PAC (PULMONARY ASSIST CIRCUIT)
    K Number
    K930252
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5240
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bird Life Design
    Date Received
    January 8, 1993
    Decision Date
    February 9, 1993
    Product Code
    CAI
    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
    CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)

    Similar 510(k) Clearances

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

    CONDENSATE COLLECTION KIT

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    UNICOR, INC. GAS SAMPLING LINES & CONNECTORS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PRIMA COAXIAL CIRCUITS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PRIMA ADULT GAS SAMPLING CIRCUITS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PRIMA PEDIATRIC ANESTHESIA CIRCUITS

    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
    K934190 HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION
    K934540 BARRIERFLEX-PF PULMONARY FUNCTION TESTING FILTER
    K933641 BLD NEONATAL HEATED WIRE BREATHING CIRCUIT- 30 VOLT COMPATIBLE
    K925543 BLD-18000 SERIES HEATED BREATHING CIRCUIT