The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Ceegraph, Modification.
Device ID | K933233 |
510k Number | K933233 |
Device Name: | CEEGRAPH, MODIFICATION |
Classification | Full-montage Standard Electroencephalograph |
Applicant | BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 -3700 |
Contact | Cathy Buhner |
Correspondent | Cathy Buhner 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 | 1993-04-21 |
Decision Date | 1994-03-03 |