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 |