The following data is part of a premarket notification filed by Lakeview Sleep Center with the FDA for Nasal Comfort Freedom.
| Device ID | K130686 |
| 510k Number | K130686 |
| Device Name: | NASAL COMFORT FREEDOM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | LAKEVIEW SLEEP CENTER 400 NORTH RAND RD North Barrington, IL 60010 |
| Contact | Andy Black |
| Correspondent | Andy Black LAKEVIEW SLEEP CENTER 400 NORTH RAND RD North Barrington, IL 60010 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-13 |
| Decision Date | 2013-10-16 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NASAL COMFORT FREEDOM 85295967 not registered Dead/Abandoned |
Buddharaju, Venkata 2011-04-15 |