The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Bio-logic Banker.
Device ID | K872290 |
510k Number | K872290 |
Device Name: | BIO-LOGIC BANKER |
Classification | Conditioner, Signal, Physiological |
Applicant | BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 -3700 |
Contact | Kamm, P.e. |
Correspondent | Kamm, P.e. BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 -3700 |
Product Code | GWK |
CFR Regulation Number | 882.1845 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-16 |
Decision Date | 1987-10-06 |