Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017638059

FEI Number

3017638059

Entity Name

Itamar Medical Ltd. (Alon)

City/State/Country

Caesarea Haifa, IL

Establishment Address

11 Alon HaTavor St, South Industrial Park, Caesarea Haifa 3079515, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ITAMAR MEDICAL INC (Owner Number: 9041901)

Owner / Operator Contact Address

3290 Cumberland Club Drive, Suite 100, Atlanta, GA 30339, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133859

PMA Number

N/A

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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2017-03-08
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2019-06-17
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2023-02-01
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-12-23
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2022-12-14
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2022-12-14
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2008-01-16
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2018-11-11
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2016-11-23
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-02-01
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2014-12-07

Official Correspondent

No official correspondent registered.

US Agent Details

Greg Mauro Email: gmauro@zoll.com Phone: (888) 7482627

Related Public Records

Same Entity

ITAMAR MEDICAL INC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003616071	ITAMAR MEDICAL	CAESAREA Haifa, IL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K082968	Apneicare, LLC	APNEICARE CONNECTION CENTER/INTERNET ANALYSIS	2009-01-02
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2022	NOX MEDICAL Keldnaholt Reykjavik Iceland	2	Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017638059. Last updated year: 2026. Please use registration number 3017638059 when referencing this establishment in official correspondence.