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

    AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER

    K Number: K051226 · Decision Nov 17, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    32
    Review Days
    189

    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
    AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER
    K Number
    K051226
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardinalhealth
    Date Received
    May 12, 2005
    Decision Date
    November 17, 2005
    Product Code
    BZD
    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
    BZD Ventilator, Non-Continuous (Respirator)

    Similar 510(k) Clearances

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

    Orion

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ResScan Essentials

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MySleepDash

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask

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

    Other Clearances by Cardinalhealth

    K Number Device Name
    K252313 Cardinal Health Nitrile Examination Gloves Extended Cuff
    K243660 Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937); Monojec
    K243652 Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE)
    K230569 Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )
    K213174 Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
    K202217 Kendall NPWT Incision Management Device
    K191101 Kendall NPWT Incision Management Dressing Kit
    K190923 Salem Sump Dual Lumen Stomach Tube with ENFit Connection
    K171499 Occlusion Detection Dressing Kit
    K161418 Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set
    Search all 32 clearances from Cardinalhealth →