Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610861

FEI Number

3002807836

Entity Name

O-TWO MEDICAL TECHNOLOGIES, INC.

City/State/Country

Brampton Ontario, CA

Establishment Address

45A Armthorpe Road, Brampton Ontario L6T 5M4, CA

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

O-TWO MEDICAL TECHNOLOGIES, INC. (Owner Number: 8020332)

Owner / Operator Contact Address

45A Armthorpe Road, --, Brampton, CA-ON L6T 5M4, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K170886

PMA Number

N/A

All Registered Proprietary Names

o_two CPAP System o_two e700, e600 and e500 O-Two Facemask Nebulizer Kit Jet Nebulizer CAREvent CA & CAREvent DRA CAREvent PAR Genesis II A/C, A/O and IDLH Equinox Relieve PRO-NOX Rescue Breather SMART BAG-MO MULTI-PATIENT UNIT Pressure Regulators for Use with Medical Gases UNIVERSAL POCKET VENTILATOR MASK, NON-REBREATHING CORRUGATED HOSE SURE FLOW TUBING Easy Grip CANNULA NASAL w/TUBING CANNULA NASAL NITRILE POWER FREE EXAM GLOVES CAREvent BLS, BLS+, ALS, ALS+, ATV CPR Bio-Barrier Facesheild Finger Tip Pulse Oximeter O-TWO REUSABLE VENTILATION CIRCUIT O-TWO DISPOSABLE VENTILATION CIRCUIT Equinox Advantage GUEDEL AIRWAY KIT GUEDEL AIRWAY CAREvent ATV+ & CAREvent MRI Mesh Nebulizer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2012-05-28
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2015-03-16
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2012-08-10
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2014-05-05
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2007-10-22
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2009-07-10
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2007-10-22
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	Class 2	868.5330	2012-05-28
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2007-10-22
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2007-10-22
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2003-08-05
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	1995-09-26
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2003-07-11
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2007-10-22
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2003-07-11
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-04-17
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2007-10-22
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2007-10-22
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2009-07-09
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2005-06-20
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	Class 2	868.5330	2018-10-25
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2005-06-20
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2007-10-22
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2026-01-28

Official Correspondent

No official correspondent registered.

US Agent Details

Jerry Doane Business: Pragmatic Compliance dba FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

O-TWO MEDICAL TECHNOLOGIES, 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
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
K945177	Eagle Health Supplies	4-O2 JR. (CPR MOUTH BARRIER)	1994-11-01
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09

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.
Z-0039-2010	Unomedical	2	Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.
Z-0040-2010	Unomedical	2	Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak.
Z-0041-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas Sampling elbow. Product ID # 5807; 12-8703, 723-E (Foreign Distribution only), 723MM. Packaged under the name of Dynarex and Evergreen.
Z-0042-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s 5808, 12-8704; 724-E; 724MM, 32612. Packaged under the name of Dynarex, Evergreen, Hospitak and Select Medical Products.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610861. Last updated year: 2026. Please use registration number 9610861 when referencing this establishment in official correspondence.