BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INNOVAMED SPHERE INC

    Reg #: 3043355869 · FEI: 3043355869 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

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    Registration Details

    Registration Name
    INNOVAMED SPHERE INC
    Registration Number
    3043355869
    FEI Number
    3043355869
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2 Bank St
    City
    Fall River
    State
    MA
    ZIP
    02720
    Country
    US

    Regulatory Submissions

    510(k) Number
    K080941

    Owner / Operator

    Firm Name
    INNOVAMED SPHERE INC
    Operator Number
    10095268
    Address
    2 Bank Strret
    City
    Fall River
    State
    MA
    Postal Code
    02720
    Country
    US
    Correspondent
    George Hattub

    Products

    Device Name Product Code
    Plethysmograph, Impedance DSB

    Proprietary Names

    BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility