The following data is part of a premarket notification filed by Ascot Pharmaceuticals, Inc. with the FDA for Rhinotherm.
| Device ID | K840118 |
| 510k Number | K840118 |
| Device Name: | RHINOTHERM |
| Classification | Humidifier, Non-direct Patient Interface (home-use) |
| Applicant | ASCOT PHARMACEUTICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KFZ |
| CFR Regulation Number | 868.5460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-11 |
| Decision Date | 1984-04-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() RHINOTHERM 88251448 not registered Live/Pending |
RHINOCARE LTD 2019-01-07 |
![]() RHINOTHERM 86966295 not registered Dead/Abandoned |
RHINOCARE LTD 2016-04-06 |
![]() RHINOTHERM 78861612 3484974 Dead/Cancelled |
ASI Solutions plc 2006-04-14 |
![]() RHINOTHERM 73440650 1300410 Dead/Cancelled |
Kibbutz Netzer Sereni 1983-08-23 |