510(k) K250651
- Device
- 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.
- 510(k) number
- K250651
- Product code
- SGR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-11-19
- Date received
- 2025-03-04
- Regulation
- 868.5895
- Classification name
- Noninvasive Positive Airway Pressure System, Facility Use
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Reena Daken
- Address
- 15 Maurice Paykel Pl., E. Tamaki Auckland NZ 2013 2013
FDA Registration Numbers#
- 3008264065
- 2085602
- 9611451
- 3015928685
Source Documents#
Other 510(k) Records For Product Code SGR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251165 | Saans (F4-01-00-000-000) | Innaccel Technologies Private Limited | 2026-01-06 |