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

    ANASCIENT BREATH MONITOR

    K Number: K110810 · Decision Jun 21, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    32
    Applicant Total
    1
    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
    ANASCIENT BREATH MONITOR
    K Number
    K110810
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Invoy Technologies, LLC
    Date Received
    March 23, 2011
    Decision Date
    June 21, 2011
    Product Code
    BZL
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BZL Computer, Oxygen-Uptake

    Similar 510(k) Clearances

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

    Breezing Med

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NICU V'02

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    METAPHOR METABOLIC MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FITMATE SERIES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EXPRESS SERIES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEDGRAPHICS ULTIMA SYSTEM

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