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

    Tec 820, Tec 850

    K Number: K172702 · Decision Jan 4, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    56
    Applicant Total
    58
    Review Days
    119

    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
    Tec 820, Tec 850
    K Number
    K172702
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5880
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Datex-Ohmeda, Inc.
    Date Received
    September 7, 2017
    Decision Date
    January 4, 2018
    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

    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

    GAV - GENERAL ANAESTHETIC VAPORIZER

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

    Other Clearances by Datex-Ohmeda, Inc.

    K Number Device Name
    K251663 Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)
    K213867 Carestation 750/750c
    K210384 CARESCAPE R860
    K172045 Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2
    K170872 Aisys CS2
    K151570 Carestation 620/650/650C
    K142679 CARESCAPE R860
    K143530 Aespire View
    K140575 ENGSTROM CARESTATION, ENGSTROM PRO
    K132530 GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)
    Search all 58 clearances from Datex-Ohmeda, Inc. →