The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Modification To Bio-logic Evoked Potential (ep) System.
| Device ID | K031009 |
| 510k Number | K031009 |
| Device Name: | MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 -3700 |
| Contact | Norman E Brunner |
| Correspondent | Norman E Brunner BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 -3700 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-31 |
| Decision Date | 2003-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830053181 | K031009 | 000 |
| 00382830052283 | K031009 | 000 |
| 00382830001427 | K031009 | 000 |
| 00382830000987 | K031009 | 000 |
| 00382830000543 | K031009 | 000 |