BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Itamar Medical Ltd. (Alon)

    Reg #: 3017638059 · FEI: 3017638059 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    39
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Itamar Medical Ltd. (Alon)
    Registration Number
    3017638059
    FEI Number
    3017638059
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    11 Alon HaTavor St, South Industrial Park
    City
    Caesarea Haifa
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K161579

    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

    Products

    Device Name Product Code
    Ventilatory Effort Recorder MNR
    Powered Laser Surgical Instrument GEX
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    WatchPAT Central+ WatchPAT Central+ kit SBP sensor Central+ sensor Watch-PAT200U (WP200U) RESBP sensor WatchPAT UnifiedPAT Probe WatchPAT200U Central+ WP200U Central+ CentralPlus sensor WatchPAT™ ONE Watch-PAT1 WatchPAT™1 Watch-PAT ONE WP1 WatchPAT1 WP 1 WatchPAT 1 WatchPAT ONE WatchPAT™ONE WatchPAT-ONE Solea WatchPAT ONE-M Probes WatchPAT200U WP200U WatchPAT-200U WatchPAT 300 WatchPAT-300 WatchPAT300 WP300 Watch-PAT300 uPAT Probe Endo PAT 2000 EPx EndoPATx Pneumatic Endo probes WATCH-PAT200U (WP200U) WP400 WatchPAT400

    Establishment Types

    Manufacture Medical Device