BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Zzoma

    Reg #: 3008812550 · FEI: 3008812550 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sleep Specialists, LLC
    Registration Number
    3008812550
    FEI Number
    3008812550
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    150 Monument Rd Ste 207
    City
    Bala Cynwyd
    State
    PA
    ZIP
    19004
    Country
    US

    Regulatory Submissions

    510(k) Number
    K100160

    Owner / Operator

    Firm Name
    2z Medical
    Operator Number
    10034700
    Address
    150 Monument Road, Suite 207, Room 222
    City
    Bala Cynwyd
    State
    PA
    Postal Code
    19004
    Country
    US
    Correspondent
    Michael J Markus

    Products

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

    Proprietary Names

    Zzoma Zzoma Positional Sleeper Zzoma Positional Device

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility