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

    AIRES

    K Number: K920043 · Decision Jun 16, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    42
    Applicant Total
    2
    Review Days
    527

    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
    AIRES
    K Number
    K920043
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5430
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Viva-Tek Assoc., Inc.
    Date Received
    January 6, 1992
    Decision Date
    June 16, 1993
    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 Viva-Tek Assoc., Inc.

    K Number Device Name
    K922110 GO-CLEAN