Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013485140

FEI Number

3013485140

Entity Name

ENGINEERING CPR INC.

City/State/Country

mississauga Ontario, CA

Establishment Address

6720 Davand Dr. - Unit 20, mississauga Ontario L5T 2K7, CA

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Engineering CPR Inc. (Owner Number: 10053917)

Owner / Operator Contact Address

6720 Davand Dr. - Unit 20, mississauga, CA-ON L5T 2K7, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Evala Envision 3D: Image Guidance System FlashLock 1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2026-03-20
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-01-22
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-03-10

Official Correspondent

Taras Worona

US Agent Details

Emily Matorin Business: FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

Engineering CPR Inc.

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
K833646	Edward Weck, Inc.	PULSATRON NERVE LOCATOR/STIMULATOR	1984-02-10
K150005	Ndi Medical, LLC	Checkpoint, Checkpoint Head & Neck	2015-02-19
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

Similar Registrations

Registration Number	Establishment Name	Location
3042364673	NEURALYTIX LLC	Fruita, CO, US
3031550429	BIOSYS BIYOMEDIKAL MUHENDISLIK SANAYI VE TICARET ANONIM SIRKETI	Cankaya Ankara, TR
1221763	ARCH Medical Solutions - Seabrook	SEABROOK, NH, US
3009959868	Ferry Machine Corporation	Little Ferry, NJ, US
2024311	PARTER MEDICAL PRODUCTS, INC.	CARSON, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013485140. Last updated year: 2026. Please use registration number 3013485140 when referencing this establishment in official correspondence.