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Hill-Rom Services Private Limited: FDA-registered device maker in Singapore North East, Singapore, 10 510(k) clearances

Name: Hill-Rom Services Private Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hill-Rom Services Private Limited is registered with the FDA (registration 3008145987) in Singapore North East, Singapore. It lists 2 device types. The FDA files 10 510(k) clearances under its listings, the newest dated March 22, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008145987
Address: 1 Yishun Avenue 7, Singapore North East, Singapore, 768923
Owner or operator: BAXTER HEALTHCARE CORPORATION (1417572)
Roles: Complaint file establishment, Specification developer
First device listed: January 10, 2022
Registered through: 2026
Brand names listed: Maximus System, MetaNeb, Metaneb, Metaneb 4, Monarch Airway Clearance System, Optimus, Synclara Cough System, The Vest APX System and more

Devices it lists

Device	Product code	Class	Role	Source
Device, Positive Pressure Breathing, Intermittent	NHJ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Percussor, Powered-Electric	BYI	2	Complaint file establishment, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 22, 2024	K233441	The Vest APX System (PVAPX1)	BYI	Substantially Equivalent	Baxter Healthcare Corportation	accessdata.fda.gov
May 26, 2020	K200988	Maximus System	NHJ	Substantially Equivalent	Hill-Rom Services Pte, Ltd.	accessdata.fda.gov
February 14, 2020	K192143	Maximus System	NHJ	Substantially Equivalent	Hill-Rom Services Pte, Ltd.	accessdata.fda.gov
March 17, 2017	K163378	Monarch Airway Clearance System	BYI	Substantially Equivalent	Hill-Rom Services Pte, Ltd.	accessdata.fda.gov
March 17, 2016	K151689	MetaNeb 4 System	NHJ	Substantially Equivalent	Hill-Rom Services Pte, Ltd.	accessdata.fda.gov
May 7, 2015	K142482	The Vest Airway Clearance System	BYI	Substantially Equivalent	Hill-Rom Services Private Limited	accessdata.fda.gov
March 28, 2014	K132988	VITAL COUGH	NHJ	Substantially Equivalent	Lung Assist, Inc.	accessdata.fda.gov
April 25, 2013	K124032	METANEB	NHJ	Substantially Equivalent	Hill-Rom Services Pte, Ltd.	accessdata.fda.gov
December 1, 2005	K051964	POWERNEB	NHJ	Substantially Equivalent	Comedica , Inc.	accessdata.fda.gov
February 21, 2003	K024309	THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104	BYI	Substantially Equivalent	Advanced Respiratory	accessdata.fda.gov

Compare with other makers

Updated March 22, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.