BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    SMART CAPNOLINE GUARDIAN

    K Number: K093388 · Decision Mar 4, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    19
    Review Days
    125

    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
    SMART CAPNOLINE GUARDIAN
    K Number
    K093388
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Oridion Medical 1987 , Ltd.
    Date Received
    October 30, 2009
    Decision Date
    March 4, 2010
    Product Code
    CCK
    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
    CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

    Similar 510(k) Clearances

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

    Capnostream™35 Portable Respiratory Monitor (PM35MN)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Medical Gas Analyzer (AG200)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AIM (N/A)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask

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

    Other Clearances by Oridion Medical 1987 , Ltd.

    K Number Device Name
    K200594 Capnostream 35 Portable Respiratory Monitor
    K181624 Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line
    K181467 Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line
    K150272 Capnostream 35 Portable Respiratory Monitor
    K123690 CAPNOSTREAM20P WITH HIFI C02 MONITORING
    K121927 MICROSTREAM FILTERLINE ICU
    K112368 CAPNOSTREAM20P WITH AI/ODI
    K042665 SMART BITEBLOC
    K024300 MICROCAP PLUS/NPB-75
    K013845 MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE
    Search all 19 clearances from Oridion Medical 1987 , Ltd. →