Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681209

FEI Number

3002628192

Entity Name

CPR Medical Devices Inc.

City/State/Country

Markham Ontario, CA

Establishment Address

161 Don Park Road, Markham Ontario L3R 1C2, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CPR MEDICAL DEVICES, INC. (Owner Number: 9061682)

Owner / Operator Contact Address

161 DON PARK RD., --, MARKHAM, CA-ON L3R 1C2, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K944349

PMA Number

N/A

All Registered Proprietary Names

Oxylator® Oxylator® FR Oxylator® EMX Oxylator® EM100 Oxylator® HD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2007-12-19

Official Correspondent

ROMEO WORNER

US Agent Details

Lawrence Kronick Business: N/A Email: larry@Bacinc.info Phone: (954) 6080259

Related Public Records

Same Entity

CPR MEDICAL DEVICES, 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
K862192	U.O. Equipment Co.	RESUSCITATOR MODELS 10400/10500/10600/10700/10800	1986-07-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2025	Mercury Enterprises, Inc. dba Mercury Medical	2	Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

Similar Registrations

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1823393	OXYGEN THERAPY INSTITUTE	Jacksonville, FL, US
3017365972	WEINMANN EMERGENCY MEDICAL TECHNOLOGY GMBH	Hamburg, DE
1924066	Allied Medical LLC	Earth City, MO, US
1625392	INTERNATIONAL BIOMEDICAL, LTD.	AUSTIN, TX, US
8044169	PLAXTRON INDUSTRIAL (M) SDN. BHD.	IPOH Perak, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681209. Last updated year: 2026. Please use registration number 9681209 when referencing this establishment in official correspondence.