F&P Airvo 3 NIV (PT311US)
FDA 510(k) K233643 · Fisher & Paykel Healthcare, Ltd.
510(k) numberK233643
Submission
- Device name
- F&P Airvo 3 NIV (PT311US)
- Applicant
- Fisher & Paykel Healthcare, Ltd.
Auckland, NZ - Received
- November 13, 2023
- Decision date
- August 9, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNT – Sv70 Ventilator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code MNT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252182 | SV70 Ventilator (SV70)MNT · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 04/06/2026SE |
| K242931 | HFT750UMNT · Traditional | Mekics Co., Ltd. | 05/15/2025SE |
| K240779 | Vivo 3MNT · Traditional | Breas Medical AB | 12/13/2024SE |
| K230173 | Servo-air Lite Ventilator SystemMNT · Traditional | Maquet Critical Care AB | 07/06/2023SE |
| K213521 | Nihon Kohden NKV-330 Ventilator SystemMNT · Traditional | Nihon Kohden Orangemed, Inc. | 07/01/2022SE |
| K191624 | F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve VersionMNT · Traditional | Fisher & Paykel Healthcare Limited | 03/09/2020SE |
| K170367 | Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large…MNT · Traditional | Fisher and Paykel Healthcare Limited | 08/24/2017SE |
| K122715 | Stellar 150MNT · Traditional | Resmed Germany, Inc. | 06/17/2013SE |
| K121623 | BIPAP a 40 Ventilatory Support SystemMNT · Abbreviated | Respironics, Inc. | 12/14/2012SE |
| K113640 | Stellar 150MNT · Traditional | Resmed Germany, Inc. | 04/05/2012SE |
More from Resmed Germany, Inc.
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| K250651 | OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS…SGR · Traditional | 11/19/2025SE |
| K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A…CBK · Traditional | 09/10/2025SE |
| K243917 | F&P Optiflow Air/Oxygen Flow SourceBZR · Traditional | 07/14/2025SE |
| K251611 | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…BTT · Special | 06/25/2025SE |
| K243583 | F&P Nova Nasal MaskBZD · Traditional | 06/18/2025SE |
| K234053 | F&P Optiflow Flow DiverterCBP · Traditional | 08/09/2024SE |
| K234058 | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)BTT · Traditional | 08/08/2024SE |
| K233821 | F&P Optiflow Oxygen Kit (AA451J)BTT · Traditional | 06/13/2024SE |
| K222292 | F&P myAirvo 3BTT · Traditional | 05/08/2024SE |
Questions and answers
When was F&P Airvo 3 NIV (PT311US) cleared by the FDA?
F&P Airvo 3 NIV (PT311US) (K233643) received a 510(k) decision of Substantially Equivalent on August 9, 2024, 270 days after the submission was received.
What is the product code of K233643?
The FDA product code is MNT – Sv70 Ventilator, a Class II (moderate risk) device regulated under 21 CFR 868.5895.