The following data is part of a premarket notification filed by Oculogica, Inc. with the FDA for Eyebox.
Device ID | K201841 |
510k Number | K201841 |
Device Name: | EyeBOX |
Classification | Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid |
Applicant | Oculogica, Inc. 33 Irving Place New York, NY 10003 |
Contact | Rosina Samadani |
Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street Suite 2300 Philadelphia, PA 19103 |
Product Code | QEA |
CFR Regulation Number | 882.1455 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-07-02 |
Decision Date | 2020-09-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00810051680003 | K201841 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EYEBOX 87644658 5764474 Live/Registered |
Patrick A. McGeehin 2017-10-13 |
EYEBOX 87570783 not registered Live/Pending |
Oculogica, Inc. 2017-08-16 |
EYEBOX 86726901 not registered Dead/Abandoned |
Oculogica Inc. 2015-08-17 |
EYEBOX 85660740 4496851 Live/Registered |
EYEOS, S.L. 2012-06-25 |
EYEBOX 85097653 4088674 Dead/Cancelled |
Walker, Sharena 2010-08-01 |
EYEBOX 78709323 not registered Dead/Abandoned |
CBS Broadcasting Inc. 2005-09-08 |
EYEBOX 75179333 not registered Dead/Abandoned |
MBS Schuberth GmbH 1996-09-30 |