The following data is part of a premarket notification filed by Ectosense Nv with the FDA for Nightowl.
Device ID | K213463 |
510k Number | K213463 |
Device Name: | NightOwl |
Classification | Ventilatory Effort Recorder |
Applicant | Ectosense Nv Bosbessenlaan 19 A Rotselaar, BE 3110 |
Contact | Bart Van Pee |
Correspondent | Bart Van Pee Ectosense Nv Bosbessenlaan 19 A Rotselaar, BE 3110 |
Product Code | MNR |
CFR Regulation Number | 868.2375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-10-27 |
Decision Date | 2021-12-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NIGHTOWL 87788973 not registered Dead/Abandoned |
Hennebry, Curtis A. 2018-02-07 |
NIGHTOWL 87163523 not registered Dead/Abandoned |
Point Of Sale System Services, Inc. 2016-09-07 |
NIGHTOWL 86946798 5122114 Live/Registered |
Point Of Sale System Services 2016-03-21 |
NIGHTOWL 85573646 4241453 Live/Registered |
DBConnect Solutions, Inc. 2012-03-19 |
NIGHTOWL 85373756 4597504 Live/Registered |
NIGHTOWL TECHNOLOGIES, INC. 2011-07-18 |
NIGHTOWL 85137122 not registered Dead/Abandoned |
Tony Risk 2010-09-23 |
NIGHTOWL 85043889 not registered Dead/Abandoned |
GATES THAT OPEN, LLC 2010-05-20 |
NIGHTOWL 79232817 not registered Live/Pending |
Ectosense 2018-03-12 |
NIGHTOWL 77578619 not registered Dead/Abandoned |
Skycam 2008-09-25 |
NIGHTOWL 77468052 3560232 Live/Registered |
Morgan Stanley 2008-05-07 |
NIGHTOWL 76237332 2790171 Dead/Cancelled |
Nascor Pty Limited 2001-04-06 |
NIGHTOWL 75744265 not registered Dead/Abandoned |
Individual Monitoring Systems, Inc. 1999-07-06 |