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

    ZZOMA POSITIONAL SLEEPER MODEL 001

    K Number: K100160 · Decision May 11, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    111

    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
    ZZOMA POSITIONAL SLEEPER MODEL 001
    K Number
    K100160
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sleep Specialists, LLC
    Date Received
    January 20, 2010
    Decision Date
    May 11, 2010
    Product Code
    MYB
    Advisory Committee
    Dental
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MYB Pillow, Cervical (For Mild Sleep Apnea)

    Similar 510(k) Clearances

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

    Lunoa System

    FDA 510(k)
    FDA Class 2 ·Dental

    NIGHT SHIFT

    FDA 510(k)
    FDA Class 2 ·Dental

    SONA PILLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    SNIFF POSITION PILLOWS/POPITZ PILLOWS

    FDA 510(k)
    FDA Class 2 ·Dental

    PILLOWPOSITIVE CERVICAL PILLOW

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