BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PROSOMNUS SLEEP TECHNOLOGIES

    Reg #: 3013116677 · FEI: 3013116677 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    15
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    PROSOMNUS SLEEP TECHNOLOGIES
    Registration Number
    3013116677
    FEI Number
    3013116677
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5675 Gibraltar Drive
    City
    Pleasanton
    State
    CA
    ZIP
    94588
    Country
    US

    Regulatory Submissions

    510(k) Number
    K172859

    Owner / Operator

    Firm Name
    ProSomnus Sleep Technologies
    Operator Number
    10053490
    Address
    5675 Gibraltar Drive
    City
    Pleasanton
    State
    CA
    Postal Code
    94588
    Country
    US
    Correspondent
    Divya Mavalli

    Products

    Device Name Product Code
    Oximeter, Wellness PGJ
    Sleep Appliances With Patient Monitoring PLC
    Device, Anti-Snoring LRK
    Medical Device Data System OUG
    Device, Jaw Repositioning LQZ
    Oximeter DQA

    Proprietary Names

    ProSomnus HWO2 Device Prosomnus CA Sleep and Snore Device Prosomnus CA Sleep and snore Device with Compliance Monitoring Prosomnus [PH] Sleep and Snore Device Prosomnus [CA] Low Profile Sleep and snore Device with Compliance Monitoring Prosomnus [PH] Sleep and Snore Device with Compliance Monitoring MicrO2 Sleep Device Prosomnus [IA] Sleep Device ProSomnus® EVO [PH] Sleep and Snore Device ProSomnus® EVO [PH] Sleep and Snore Device with Patient Monitoring ProSomnus RPMO2 OSA Device ProSomnus® EVO Sleep and Snore Device ProSomnus® EVO Sleep and Snore Device with Patient Monitoring MicrO2 Sleep Device with MicroRecorder Prosomnus [IA] Sleep Device with MicroRecorder

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device