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

    OHMEDA TEC 5 VAPORIZER FOR USE WITH SEVOFLURANE

    K Number: K942091 · Decision Mar 30, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    56
    Applicant Total
    120
    Review Days
    332

    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
    OHMEDA TEC 5 VAPORIZER FOR USE WITH SEVOFLURANE
    K Number
    K942091
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5880
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ohmeda Medical
    Date Received
    May 2, 1994
    Decision Date
    March 30, 1995
    Product Code
    CAD
    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
    CAD Vaporizer, Anesthesia, Non-Heated

    Similar 510(k) Clearances

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

    V80 Anesthetic Vaporizer (V80)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Tec 820, Tec 850

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    V60 Anesthetic Vaporizer

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SEVOFLURANE VAPORIZER ADAPTOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SIGMA ALPHA VAPORIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454

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

    Other Clearances by Ohmeda Medical

    K Number Device Name
    K123309 GIRAFFE AND PANDA WARMERS
    K101788 GIRAFFE OMNIBED
    K101778 GIRAFFE INCUBATOR
    K090697 MODIFICATION TO: GIRAFFE AND PANDA WARMER
    K072157 MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
    K070377 GIRAFFE AND PANDA WARMER
    K070210 GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
    K070247 GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
    K040068 BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
    K020543 OHMEDA MEDICAL GIRAFFE OMNIBED
    Search all 120 clearances from Ohmeda Medical →