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 |