The following data is part of a premarket notification filed by Eemagine Medical Imaging Solutions Gmbh with the FDA for Cognitrace.
Device ID | K051825 |
510k Number | K051825 |
Device Name: | COGNITRACE |
Classification | Full-montage Standard Electroencephalograph |
Applicant | EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH PO BOX 7007 Deerfield, IL 60015 |
Contact | Daniel Kamm |
Correspondent | Daniel Kamm EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH PO BOX 7007 Deerfield, IL 60015 |
Product Code | GWQ |
CFR Regulation Number | 882.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-05 |
Decision Date | 2005-09-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B195SC100 | K051825 | 000 |
B195LE200 | K051825 | 000 |
B195LC107 | K051825 | 000 |
B195LC106 | K051825 | 000 |
B195LC105 | K051825 | 000 |
B195LC104 | K051825 | 000 |
B195ES220 | K051825 | 000 |
B195LC100 | K051825 | 000 |