Oxymag - Transport and Emergency Ventilator
FDA 510(k) K221634 · Magnamed Tecnologia Medica S/A
510(k) numberK221634
Submission
- Device name
- Oxymag - Transport and Emergency Ventilator
- Applicant
- Magnamed Tecnologia Medica S/A
Cotia, BR - Received
- June 6, 2022
- Decision date
- May 24, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTL – Ventilator, Emergency, Powered (Resuscitator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5925
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code BTL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242769 | VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)BTL · Traditional | Draegerwerk AG & CO Kgaa | 04/04/2025SE |
| K202219 | VORTRAN GO2VENT with PEEP ValveBTL · Traditional | Vortran Medical Technology 1, Inc. | 02/11/2021SE |
| K193191 | MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagBTL · Traditional | Weinmann Emergency Medical Technology GmbH + Co.… | 11/20/2020SE |
| K182956 | Puffin Lite Infant Resuscitation SystemBTL · Special | International Biomedical | 01/18/2019SE |
| K173373 | SafeT T-Piece ResuscitatorBTL · Traditional | Ventlab, LLC | 11/16/2018SE |
| K161420 | Moves SLCBTL · Traditional | Thornhill Research, Inc. | 06/06/2017SE |
| K162968 | Vortran GO2VENTBTL · Traditional | Vortran Medical Technology 1, Inc. | 04/10/2017SE |
| K141595 | O-Two E700,O-TWO E600,O-TWO E500BTL · Traditional | O-Two Medical Technologies, Inc. | 03/16/2015SE |
| K142096 | T-Piece ResuscitatorBTL · Traditional | Mercury Medical | 10/17/2014SE |
| K140049 | Moves SLCBTL · Traditional | Thornhill Research, Inc. | 05/29/2014SE |
Questions and answers
When was Oxymag - Transport and Emergency Ventilator cleared by the FDA?
Oxymag - Transport and Emergency Ventilator (K221634) received a 510(k) decision of Substantially Equivalent on May 24, 2023, 352 days after the submission was received.
What is the product code of K221634?
The FDA product code is BTL – Ventilator, Emergency, Powered (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5925.