The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Photic Stimulator Models 580-pscomp,psceeg,psstal.
| Device ID | K874136 |
| 510k Number | K874136 |
| Device Name: | PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 -3700 |
| Contact | Thomas Nall |
| Correspondent | Thomas Nall BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 -3700 |
| Product Code | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-13 |
| Decision Date | 1988-03-25 |