Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010223399

FEI Number

3010223399

Entity Name

SHAHAK-TEC LTD.

City/State/Country

Zichron Yaakov Haifa, IL

Establishment Address

1, Avshalom Road, POB 166, Zichron Yaakov Haifa 3095101, IL

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Shahak-Tec Ltd. (Owner Number: 10042902)

Owner / Operator Contact Address

1, AvShalom Road, POB 166, Zichron Yaakov, IL-NOTA 3095101, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Smart CapnoLine Plus H O2 Smart CapnoLine O2 Pediatric Smart CapnoLine Plus O2 LONG Smart CapnoLine Plus O2 Smart CapnoLine Guardian Smart CapnoLine Guardian LONG CAPNOLINE H O2 ADULT Smart SureLine Plus O2 Watertrap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-01-10
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-01-10
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2019-10-10
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-01-10
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-01-10
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2014-11-24

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Shahak-Tec 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
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04
K172904	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Capnography Extension, IntelliVue Microstream Extension	2017-12-26
K820587	Abco Dealers, Inc.	WET PACK LINE OF PRODUCTS	1982-03-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010223399. Last updated year: 2026. Please use registration number 3010223399 when referencing this establishment in official correspondence.