The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Homelox.
| Device ID | K081206 |
| 510k Number | K081206 |
| Device Name: | HOMELOX |
| Classification | Generator, Oxygen, Portable |
| Applicant | RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Contact | Zita A Yurko |
| Correspondent | Zita A Yurko RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-29 |
| Decision Date | 2008-07-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HOMELOX 77193957 4022966 Dead/Cancelled |
RIC Investments, LLC 2007-05-31 |