BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    The iNAP One Sleep Therapy System

    K Number: K193460 · Decision May 26, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    162

    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
    The iNAP One Sleep Therapy System
    K Number
    K193460
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Somnice, Inc.
    Date Received
    December 16, 2019
    Decision Date
    May 26, 2020
    Product Code
    OZR
    Advisory Committee
    Dental
    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
    OZR Intraoral Pressure Gradient Device

    Similar 510(k) Clearances

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

    The iNAP One Sleep Therapy System

    FDA 510(k)
    FDA Class 2 ·Dental

    WINX SLEEP THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    WINX SLEEP THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    WINX SLEEP THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ATTUNE SLEEP APNEA SYSTEM

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