The following data is part of a premarket notification filed by Clark Davis Medical Systems, Inc. with the FDA for Advantage Ep.
Device ID | K903734 |
510k Number | K903734 |
Device Name: | ADVANTAGE EP |
Classification | Stimulator, Photic, Evoked Response |
Applicant | CLARK DAVIS MEDICAL SYSTEMS, INC. 1764 OXFORD ST. London, Ontario, CA N5v 3r6 |
Contact | Michael Clark |
Correspondent | Michael Clark CLARK DAVIS MEDICAL SYSTEMS, INC. 1764 OXFORD ST. London, Ontario, CA N5v 3r6 |
Product Code | GWE |
CFR Regulation Number | 882.1890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-16 |
Decision Date | 1991-07-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ADVANTAGE EP 77940028 not registered Dead/Abandoned |
H2O Jet 2010-02-19 |