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Braebon Medical Corp.: FDA-registered device maker in KANATA Ontario, Canada, 8 510(k) clearances

Name: Braebon Medical Corp. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Braebon Medical Corp. is registered with the FDA (registration 3002912391) in KANATA Ontario, Canada. It lists 8 device types. The FDA files 8 510(k) clearances under its listings, the newest dated July 16, 2009. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3002912391
Address: 1-100 Schneider Road, KANATA Ontario, Canada, K2K 1Y2
Owner or operator: BRAEBON MEDICAL CORP. (9041773)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: June 20, 2002
Registered through: 2026
Brand names listed: Adult Airflow Thermocouple, BRAEBON Paper Tape, CPAPFresh, Disposable RIP Belt, Disposable cTherm, Dual Pressure Sensor Safety Filter + Adapter, EKG ELIMINATOR, Leadwire Kit for MediByte and more

Devices it lists

Device	Product code	Class	Role	Source
Cable, Electrode	IKD	2	Manufacturer	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Manufacturer	accessdata.fda.gov
Cleaner, Denture, Mechanical	JER	1	Specification developer	accessdata.fda.gov
Device, Anti-Snoring	LRK	2	Repackager or relabeler	accessdata.fda.gov
Device, Sleep Assessment	LEL	2	Manufacturer	accessdata.fda.gov
Monitor, Breathing Frequency	BZQ	2	Manufacturer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Repackager or relabeler	accessdata.fda.gov
Ventilatory Effort Recorder	MNR	2	Manufacturer	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
July 16, 2009	K082849	SILENT SLEEP	LRK	Substantially Equivalent	Craniofacial Pain Center of Idaho	accessdata.fda.gov
September 6, 2006	K061764	MEDIBYTE, MODEL MP8	MNR	Substantially Equivalent	Braebon Medical Corp.	accessdata.fda.gov
August 7, 2002	K020312	ULTIMA SNORING MIKE, MODEL 0540	MNR	Substantially Equivalent	Braebon Medical Corp.	accessdata.fda.gov
August 25, 2000	K001743	ULTIMA SMARTBELT, MODEL 0560	BZQ	Substantially Equivalent	Braebon Medical Corp.	accessdata.fda.gov
December 30, 1998	K984431	ULTIMA AIRFLOW PRESSURE SENSOR	BZQ	Substantially Equivalent	Braebon Medical Corp.	accessdata.fda.gov
October 5, 1998	K981445	ULTIMA AIRFLOW SENSOR, 0510	BZQ	Substantially Equivalent	Braebon Medical Corp.	accessdata.fda.gov
September 11, 1998	K982216	ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522	BZQ	Substantially Equivalent	Braebon Medical Corp.	accessdata.fda.gov
August 20, 1998	K981969	ULTIMA BODY POSITION SENSOR	LEL	Substantially Equivalent	Braebon Medical Corp.	accessdata.fda.gov

Compare with other makers

Updated July 16, 2009. 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.