BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACCUTRON, INC.

    Reg #: 2020813 · FEI: 2020813 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    10
    Establishment Types
    3
    Classifications
    13

    Registration Details

    Registration Name
    ACCUTRON, INC.
    Registration Number
    2020813
    FEI Number
    2020813
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1625 W Pinnacle Peak Rd
    City
    PHOENIX
    State
    AZ
    ZIP
    85027
    Country
    US

    Regulatory Submissions

    510(k) Number
    K965239

    Owner / Operator

    Firm Name
    Accutron Inc
    Operator Number
    2020813
    Address
    1625 W Pinnacle Peak Rd
    City
    Phoenix
    State
    AZ
    Postal Code
    85027
    Country
    US
    Correspondent
    Katy Peterson

    Products

    Device Name Product Code
    Yoke Assembly, Medical Gas CAM
    Mask, Oxygen BYG
    Apparatus, Gas-Scavenging CBN
    Gas-Machine, Anesthesia BSZ
    Connector, Airway (Extension) BZA
    Regulator, Pressure, Gas Cylinder CAN
    Bag, Reservoir BTC
    Mask, Oxygen, Non-Rebreathing KGB
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Transducer, Gas Pressure BXO
    Tubing, Pressure And Accessories BYX
    Gauge, Gas Pressure, Cylinder/Pipeline BXH
    Mask, Scavenging KHA

    Proprietary Names

    YOKE ASSEMBLY, MEDICAL GAS ACCUTRON Gas-machine, anesthesia REGULATOR, PRESSURE, GAS CYLINDER BAG, RESERVOIR Ventilator, emergency, manual (resuscitator) TRANSDUCER, GAS PRESSURE TUBING, PRESSURE AND ACCESSORIES GAUGE, GAS PRESSURE, CYLINDER/PIPELINE Apparatus, Gas-Scavenging

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198