510(k) K251611 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
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., Auckland, NZ |
| Decision | Substantially Equivalent, Jun 25, 2025 |
| Received | May 27, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K251611
No recall in the FDA data names this 510(k).
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