ONZ — Mechanical Ventilator Class II
FDA product code ONZ covers "Mechanical Ventilator", a Class II medical device regulated under 21 CFR 868.5895. Submissions are reviewed by the Anesthesiology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ONZ
- Device Class
- Class II
- Regulation Number
- 868.5895
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Definition
This device is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or caregiver under the direction of a physician,
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K152664 | new aera | TAV System | December 2, 2016 |
| K131562 | breathe technologies | BREATHE NIOV VENTILATION SYSTEM | March 6, 2014 |
| K103345 | breathe technologies | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) | February 11, 2011 |
| K102525 | breathe technologies | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) | December 2, 2010 |
| K100528 | breathe technologies | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S | April 23, 2010 |
| K082982 | breathe technologies | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES | July 20, 2009 |