Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020476987

FEI Number

3020476987

Entity Name

LINAMAR INNOVATION HUB

City/State/Country

Guelph Ontario, CA

Establishment Address

750 Woodlawn Road West, Guelph Ontario N1K 1G4, CA

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Linamar Innovation Hub (Owner Number: 10082640)

Owner / Operator Contact Address

750 Woodlawn Road West, Guelph, CA-ON N1K 1G4, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Moves SLC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2021-08-30
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2021-08-30
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2021-08-30
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2021-08-30

Official Correspondent

Julio Mendez

US Agent Details

Richard Keen Business: Compliance Consultants Email: rk@complianceconsultants.US Phone: (203) 3292700

Related Public Records

Same Entity

Linamar Innovation Hub

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
K071802	Mammendorfer Institut Fur Physik Und Medizin GmbH	TESLA GUARD, MODEL EFT G04	2007-11-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2007	Haemonetics Corporation	2	SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US
Z-0038-2007	Sunrise Medical	2	DeVilbiss iFill Personal Oxygen Station model number 535D.
Z-0001-2015	Invivo Corporation	2	Philips Expression MR200 MRI Patient Monitoring System Model 866120
Z-0004-2023	Philips North America Llc	2	MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Z-0011-04	GE Medical Systems Information Technologies	2	Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug.

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3005168196	PENUMBRA, INC.	Alameda, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020476987. Last updated year: 2026. Please use registration number 3020476987 when referencing this establishment in official correspondence.