ITAMAR MEDICAL

FDA Device Registration & Listing · CAESAREA Haifa, IL · Registration 3003616071

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003616071
FEI Number
3003616071
Entity Name
ITAMAR MEDICAL
City/State/Country
CAESAREA Haifa, IL
Establishment Address
9 Halamish ST., CAESAREA Haifa 3088900, 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
N
Expiration Date (Year)
2026
510(k) Number
K211557
PMA Number
N/A

All Registered Proprietary Names

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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OUG Medical Device Data System General Hospital Class 1 880.6310 2018-05-07
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2017-03-08
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2018-11-11
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 2016-11-23
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2025-11-24
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2014-12-07
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2022-12-14
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2023-02-01

Official Correspondent

No official correspondent registered.

US Agent Details

Greg Mauro Business: ITAMAR MEDICAL, INC 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
3017638059 Itamar Medical Ltd. (Alon) 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, PA***SLT Fiber Delivery System***Sterile***Non-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 3003616071. Last updated year: 2026. Please use registration number 3003616071 when referencing this establishment in official correspondence.
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