F&P Airvo 3 NIV (PT311US)— 510(k) K233643
Substantially EquivalentFisher & Paykel Healthcare, Ltd.
FDA 510(k) clearance K233643 for F&P Airvo 3 NIV (PT311US), Substantially Equivalent on 2024-08-09. Applicant: Fisher & Paykel Healthcare, Ltd.. Device class: 2.
Clearance details
- Applicant
- Fisher & Paykel Healthcare, Ltd.
- Product code
- Code MNT
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Auckland, NZ
Recent devices under product code MNT
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- K250651 — OptiPAP Junior Flexi Tube US (OPTIPAPFUS) +10 more
- K252173 — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A) +3 more
- K243917 — F&P Optiflow Air/Oxygen Flow Source
- K251611 — Optiflow+ Nasal Cannula - Small (OPT942) +5 more
Adverse events under product code MNT
product code MNT- Death
- 118
- Injury
- 324
- Malfunction
- 25,451
- Other
- 2
- Total
- 25,895
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.