K251611
- 510(k) number
- K251611
- Device name
- Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)
- Applicant
- Fisher & Paykel Healthcare, Ltd. NZ
- Product code
- BTT — Humidifier, Respiratory Gas, (Direct Patient Interfa
- Decision date
- 2025-06-25
- Date received
- 2025-05-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251611.pdf
Official FDA record: K251611
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.