NONAGON LTD.

FDA Device Registration & Listing · Caesarea Haifa, IL · Registration 3018783553

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
3018783553
FEI Number
3018783553
Entity Name
NONAGON LTD.
City/State/Country
Caesarea Haifa, IL
Establishment Address
1 HaEshel Street, Caesarea Haifa 3079830, IL
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Nonagon Ltd. (Owner Number: 10081507)
Owner / Operator Contact Address
1 HaEshel Street, Caesarea, IL-NOTA 3079830, IL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K202483
PMA Number
N/A

All Registered Proprietary Names

Nonagon N9+ Accessories Kit Nonagon N9+ Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FXG Specula Accessories General, Plastic Surgery Class 1 878.1800 2021-08-30
DQA Oximeter Cardiovascular Class 2 870.2700 2021-04-21
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 2021-04-21
DQD Stethoscope, Electronic Cardiovascular Class 2 870.1875 2021-04-21
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2021-04-21

Official Correspondent

Sagi Peled

US Agent Details

Isaac Elkah Business: Preferred Depot Email: Sagi@Nonagon-Care.com Phone: (844) 7702727

Related Public Records

Same Entity

Nonagon Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23
K973147 Nellcor Puritan Bennett, Inc. NPB-295 PULSE OXIMETER 1997-11-14
K231243 Guangdong Genial Technology Co., Ltd. Finger Clip Pulse Oximeter 2023-10-31
K971628 Somanetics Corp. SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) 1997-10-10
K153184 Shenzhen Caremed Medical Technology Co., Ltd. Caremed Reusable & Disposable SPO2 Sensors 2017-01-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653
Z-0029-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018783553. Last updated year: 2026. Please use registration number 3018783553 when referencing this establishment in official correspondence.
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