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

    COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800)

    K Number: K921809 · Decision Dec 4, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    110
    Review Days
    233

    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
    COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800)
    K Number
    K921809
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Puritan Bennett Corp.
    Date Received
    April 15, 1992
    Decision Date
    December 4, 1992
    Product Code
    CAF
    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
    CAF Nebulizer (Direct Patient Interface)

    Similar 510(k) Clearances

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

    FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    eRapid with eTrack System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Mesh Nebulizer (H6)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Portable mesh nebulizer (JM821)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HeroTracker Sense

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

    Other Clearances by Puritan Bennett Corp.

    K Number Device Name
    K063650 VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840
    K053388 MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION
    K023225 PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE
    K022103 PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM
    K001646 PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION
    K002001 BREEZE SLEEPGEAR WITH DREAMSEAL
    K993071 PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840
    K993220 PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM
    K993088 PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI
    K984535 PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION
    Search all 110 clearances from Puritan Bennett Corp. →