The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Ceegraph.
Device ID | K895125 |
510k Number | K895125 |
Device Name: | CEEGRAPH |
Classification | Full-montage Standard Electroencephalograph |
Applicant | BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 -3700 |
Contact | Gil Raviv |
Correspondent | Gil Raviv BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 -3700 |
Product Code | GWQ |
CFR Regulation Number | 882.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-08-15 |
Decision Date | 1989-12-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CEEGRAPH 76552298 2894883 Dead/Cancelled |
NATUS MEDICAL INCORPORATED 2003-10-17 |