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

    MODEL 5000 MULTIPLACE HYPERBARIC THERAPY

    K Number: K002794 · Decision Dec 6, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    68
    Applicant Total
    2
    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
    MODEL 5000 MULTIPLACE HYPERBARIC THERAPY
    K Number
    K002794
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5470
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hypertec, Inc.
    Date Received
    September 7, 2000
    Decision Date
    December 6, 2000
    Product Code
    CBF
    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
    CBF Chamber, Hyperbaric

    Similar 510(k) Clearances

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

    FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Revitalair 430+

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Revitalair 430F

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OxyHeal 4000 Multiplace Hyperbaric Chamber Family

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER

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

    Other Clearances by Hypertec, Inc.

    K Number Device Name
    K002795 MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS