510(k) K243583
K243583 is an FDA 510(k) premarket notification submitted by Fisher & Paykel Healthcare Limited for the device "F&P Nova Nasal Mask". The FDA issued a decision of Substantially Equivalent on June 18, 2025. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Fisher & Paykel Healthcare Limited has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 18, 2025
- Date Received
- November 20, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Non-Continuous (Respirator)
- Device Class
- Class II
- Regulation Number
- 868.5905
- Review Panel
- AN
- Submission Type