BEUDAMED
    FDA Registration Active 🇵🇪 Peru

    OXICAB ML-60

    Reg #: 3007127387 · FEI: 3007127387 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HYPERBARIC S.A.C.
    Registration Number
    3007127387
    FEI Number
    3007127387
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    AV. PEDRO HUILCA MZ. C, LOTE 9, Parque Ind PARQUE INDUSTRIAL, PARC II, VILLA EL SALVADOR
    City
    Lima Lima (Region)
    Country
    PE

    Regulatory Submissions

    510(k) Number
    K081506

    Owner / Operator

    Firm Name
    Hyperbaric S.A.C.
    Operator Number
    10026695
    Address
    AV. PEDRO HUILCA MZ. C, LOTE 9, PARQUE INDUSTRIAL, PARC II
    City
    VILLA EL SALVADOR
    State
    Lima
    Postal Code
    15816
    Country
    PE

    US Agent

    Business Name
    mdi Consultants, Inc.
    Contact Name
    Alan Schwartz
    Address
    55 Northern Blvd.
    City
    Great Neck
    State
    NY
    ZIP
    11021
    Country
    US
    Email
    [email protected]
    Phone
    516 4829001

    Products

    Device Name Product Code
    Chamber, Hyperbaric CBF

    Proprietary Names

    OXICAB ML-60 OXICAB MO-13 OXICAB ML-4BZ-18

    Establishment Types

    Manufacture Medical Device