Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030970580

FEI Number

3030970580

Entity Name

RMO

City/State/Country

Johor Bahru, MY

Establishment Address

19, Jalan Firma 1/5, Kawasan Perindustrian Tebrau 1, Johor Bahru 81100, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

RESMED CORP. (Owner Number: 9002319)

Owner / Operator Contact Address

9001 Spectrum Center Blvd, --, San Diego, CA 92123, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AirFit F20 F20 QuietAir Elbow

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2023-11-14
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2016-11-17
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2007-01-25
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2014-03-13
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2008-02-08
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2011-01-06
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2018-07-11
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2004-06-18
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2026-03-19
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2019-05-19
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2008-02-11
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2011-07-26

Official Correspondent

David Lanfranchi

US Agent Details

David Lanfranchi Business: ResMed Corp Email: RegulatoryTeam-Americas@ResMed.com Phone: (858) 8365000

Related Public Records

Same Entity

RESMED CORP.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3017684630	ResMed Asia Pte. Ltd.	Singapore South West, SG
3011205710	ResMed Corp	Lithia Spgs, GA, US
3007009701	ResMed West Coast Warehouse	Moreno Valley, CA, US
3007573469	RESMED CORP	San Diego, CA, US
3038236812	ResMed Malaysia Operations Sdn Bhd	Senai Johor, MY

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24
K082979	Resmed, Ltd.	S8 ADVANCE	2009-01-02
K203126	Resmed Pty , Ltd.	S10 Kirra	2020-12-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

Similar Registrations

Registration Number	Establishment Name	Location
3012667060	HMC Premedical S.p.A.	Medolla Modena, IT
3013505405	BMC (Tianjin) Medical Co., Ltd.	Wuqing District Tianjin, CN
3033530343	BMC INVESTMENT HOLDING LIMITED	Hong Kong, HK
3017684630	ResMed Asia Pte. Ltd.	Singapore South West, SG
3042507287	3B MEDICAL INC	W Jefferson, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030970580. Last updated year: 2026. Please use registration number 3030970580 when referencing this establishment in official correspondence.