SLEEPSCAN
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
BIOLOGIC SYSTEMS CORP.
The following data is part of a premarket notification filed by Biologic Systems Corp. with the FDA for Sleepscan.
Pre-market Notification Details
| Device ID | K894155 |
| 510k Number | K894155 |
| Device Name: | SLEEPSCAN |
| Classification | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| Applicant | BIOLOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 |
| Contact | Gil Raviv |
| Correspondent | Gil Raviv BIOLOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 |
| Product Code | OLZ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-14 |
| Decision Date | 1990-01-26 |
Trademark Results [SLEEPSCAN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SLEEPSCAN 86478864 4920597 Live/Registered |
Tanita Corporation 2014-12-12 |
 SLEEPSCAN 76552851 2894888 Dead/Cancelled |
NATUS MEDICAL INCORPORATED 2003-10-17 |
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