The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Modification To Bio-logic Sleepscan.
| Device ID | K983913 |
| 510k Number | K983913 |
| Device Name: | MODIFICATION TO BIO-LOGIC SLEEPSCAN |
| Classification | Standard Polysomnograph With Electroencephalograph |
| 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 | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-04 |
| Decision Date | 1998-11-25 |
| Summary: | summary |