Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011895992

FEI Number

3011895992

Entity Name

GAS CONTROL EQUIPMENT LTD

City/State/Country

Haydock St. Helens, GB

Establishment Address

100 Empress Park, Penny Lane, Haydock St. Helens WA119DB, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Gas Control Equipment LTD (Owner Number: 10056354)

Owner / Operator Contact Address

100 Empress Park, Penny Lane, Haydock, GB-SHN WA119DB, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162433

PMA Number

N/A

All Registered Proprietary Names

GCE Zen-O Lite Clarity Portable Oxygen Concentrator Model RS-00600C GCE Zen-O Portable Oxygen Concentrator Model RS-00500 GCE Zen-O Clarity Portable Oxygen Concentrator Model RS-00500C ARYA Zen-O Lite Portable Oxygen Concentrator Model RS-00600 GCE Zen-O Lite Portable Oxygen Concentrator Model RS-00600

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2017-12-01

Official Correspondent

No official correspondent registered.

US Agent Details

JESSICA BARRILE Business: Ohio Medical LLC Email: JESSICA.BARRILE@OHIOMEDICAL.COM Phone: (847) 8556318

Related Public Records

Same Entity

Gas Control Equipment 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
K003939	Invacare Corp.	VENTURE HOME FILL II, MODEL IOH 200	2001-03-21
K942357	Healthdyne, Inc.	H-500 ALLIANCE OXYGEN CONCENTRATOR	1994-05-27
K042262	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10	2004-09-10
K003472	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM	2001-06-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-2007	Sunrise Medical	2	DeVilbiss iFill Personal Oxygen Station model number 535D.

Similar Registrations

Registration Number	Establishment Name	Location
3004964590	AVOX SYSTEMS	Lancaster, NY, US
3008841036	Oxus America, Inc.	Orion Township, MI, US
3016809216	GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO., LTD.	Guangzhou City Guangdong, CN
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ
3013095415	VENTEC LIFE SYSTEMS, INC.	Bothell, WA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011895992. Last updated year: 2026. Please use registration number 3011895992 when referencing this establishment in official correspondence.