The following data is part of a premarket notification filed by Nicolet Biomedical, Inc. with the FDA for Brainet.
Device ID | K021986 |
510k Number | K021986 |
Device Name: | BRAINET |
Classification | Electrode, Cutaneous |
Applicant | NICOLET BIOMEDICAL, INC. 800 LEVANGER LN. Stoughton, WI 53589 |
Contact | Gary Syring |
Correspondent | Gary Syring NICOLET BIOMEDICAL, INC. 800 LEVANGER LN. Stoughton, WI 53589 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-06-18 |
Decision Date | 2002-08-23 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BRAINET 78112991 2748897 Live/Registered |
Jordan Neuroscience, Inc. 2002-03-06 |
BRAINET 77685987 3688847 Dead/Cancelled |
Brainet Toys and Games, LLC. 2009-03-08 |
BRAINET 75314689 not registered Dead/Abandoned |
Siemens Aktiengesellschaft 1997-06-25 |