BEUDAMED
    FDA Registration Active 🇺🇸 United States

    The iNAP One Sleep Therapy System

    Reg #: 3017791238 · FEI: 3017791238 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Somnics Health
    Registration Number
    3017791238
    FEI Number
    3017791238
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    370 Convention way
    City
    Redwood City
    State
    CA
    ZIP
    94063
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220907

    Owner / Operator

    Firm Name
    Somnics, Inc.
    Operator Number
    10058120
    Address
    5F, No. 22, Sec. 2, Shengyi Rd., Hsinchu Science Park,
    City
    Zhubei City
    State
    Hsinchu
    Postal Code
    30261
    Country
    TW

    Products

    Device Name Product Code
    Intraoral Pressure Gradient Device OZR

    Proprietary Names

    The iNAP One Sleep Therapy System iBreath

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198