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

    MODEL 4100 MICROSURGICAL CO2 LASER SYSTEM

    K Number: K837110 · Decision Mar 11, 1983
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    6
    Review Days
    63

    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
    MODEL 4100 MICROSURGICAL CO2 LASER SYSTEM
    K Number
    K837110
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Applicant
    Bio Quantum Technologies, Inc.
    Date Received
    January 7, 1983
    Decision Date
    March 11, 1983
    Advisory Committee
    Unknown
    Review Advisory Committee
    RA
    Third Party
    N

    Other Clearances by Bio Quantum Technologies, Inc.

    K Number Device Name
    K934089 BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S
    K864946 ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE
    K864887 ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU
    K864948 ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE
    K840406 MICROSURGICAL CO2 LASER SYS - 4100