BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Solea

    Reg #: 3003616071 · FEI: 3003616071 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ITAMAR MEDICAL
    Registration Number
    3003616071
    FEI Number
    3003616071
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9 Halamish ST.
    City
    CAESAREA Haifa
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K223675

    Owner / Operator

    Firm Name
    ITAMAR MEDICAL INC
    Operator Number
    9041901
    Address
    3290 Cumberland Club Drive, Suite 100
    City
    Atlanta
    State
    GA
    Postal Code
    30339
    Country
    US

    US Agent

    Business Name
    ITAMAR MEDICAL, INC
    Contact Name
    Greg Mauro
    Address
    3290 CUMBERLAND CLUB DR , STE 100
    City
    ATL
    State
    GA
    ZIP
    30339
    Country
    US
    Email
    [email protected]
    Phone
    888 7482627 ext. 219

    Products

    Device Name Product Code
    Ventilatory Effort Recorder MNR
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Solea WatchPAT ONE Watch-PAT1 WP1 Watch-PAT ONE WatchPAT-ONE WatchPAT ONE-M Probes WatchPAT™ONE

    Establishment Types

    Manufacture Medical Device