510(k) K233643
K233643 is an FDA 510(k) premarket notification submitted by Fisher & Paykel Healthcare, Ltd. for the device "F&P Airvo 3 NIV (PT311US)". The FDA issued a decision of Substantially Equivalent on August 9, 2024. The device falls under product code MNT (Sv70 Ventilator), a Class II device regulated under 21 CFR 868.5895. Fisher & Paykel Healthcare, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 9, 2024
- Date Received
- November 13, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sv70 Ventilator
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type