OptiPillows EPAP Mask
Dilator, Nasal
Cpapnea Medical Supply
The following data is part of a premarket notification filed by Cpapnea Medical Supply with the FDA for Optipillows Epap Mask.
Pre-market Notification Details
| Device ID | K181219 |
| 510k Number | K181219 |
| Device Name: | OptiPillows EPAP Mask |
| Classification | Dilator, Nasal |
| Applicant | Cpapnea Medical Supply 10443 N Cave Creek Rd, Suite 110 Phoenix, AZ 85020 |
| Contact | Sal T. Hakim |
| Correspondent | Sal T. Hakim Cpapnea Medical Supply 10443 N Cave Creek Road, Suite 110 Phoenix, AZ 85020 |
| Product Code | LWF |
| CFR Regulation Number | 874.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-07 |
| Decision Date | 2018-08-03 |
| Summary: | summary |
Trademark Results [OptiPillows EPAP Mask]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTIPILLOWS EPAP MASK 90774469 not registered Live/Pending |
Hakim, Sal 2021-06-15 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.