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

    COMFORT CUSHION DISPOS. ANALGESIS

    K Number: K832752 · Decision Dec 8, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    42
    Applicant Total
    2
    Review Days
    115

    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
    COMFORT CUSHION DISPOS. ANALGESIS
    K Number
    K832752
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5430
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Mission Dental, Inc.
    Date Received
    August 15, 1983
    Decision Date
    December 8, 1983
    Product Code
    CBN
    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
    CBN Apparatus, Gas-Scavenging

    Similar 510(k) Clearances

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

    Nitronox Scavenger Plus

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Dynamic Gas Scavenging System 2 (DGSS - 2)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MINISCAV

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ISO-GARD MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ISO-GARD MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ISO-GARD CLEARAIR MASK

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

    Other Clearances by Mission Dental, Inc.

    K Number Device Name
    K792157 DENTAL MOUTHPROP (BITE BLOCK)