510(k) K251165
- Device
- Saans (F4-01-00-000-000)
- Applicant
- Innaccel Technologies Private Limited
- 510(k) number
- K251165
- Product code
- SGR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-01-06
- Date received
- 2025-04-15
- 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
- Vijayarajan Alagumalai
- Address
- Aanand Towers, No-4, 5th Floor,Raja Rammohan Roy Rd. Ward #77, Sampangi Rama Nagar Bengaluru IN 560025 560025
FDA Registration Numbers#
- 3008264065
- 2085602
- 9611451
- 3015928685
Source Documents#
Other 510(k) Records For Product Code SGR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250651 | 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 | Fisher & Paykel Healthcare, Ltd. | 2025-11-19 |