OptiPAP Junior Flexi Tube US (OPTIPAPFUS) +10 more— 510(k) K250651
Substantially EquivalentFisher & Paykel Healthcare, Ltd.
FDA 510(k) clearance K250651 for OptiPAP Junior Flexi Tube US (OPTIPAPFUS) +10 more, Substantially Equivalent on 2025-11-19. Applicant: Fisher & Paykel Healthcare, Ltd.. Device class: 2.
Clearance details
- Device name as filed
- OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun
- Applicant
- Fisher & Paykel Healthcare, Ltd.
- Product code
- Code SGR
- 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
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Data sourced from openFDA. This site is unofficial and independent of the FDA.