ACTITRAC
Full-montage Standard Electroencephalograph
INDIVIDUAL MONITORING SYSTEMS, INC.
The following data is part of a premarket notification filed by Individual Monitoring Systems, Inc. with the FDA for Actitrac.
Pre-market Notification Details
| Device ID | K992410 |
| 510k Number | K992410 |
| Device Name: | ACTITRAC |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | INDIVIDUAL MONITORING SYSTEMS, INC. 1055 TAYLOR AVE., SUITE 300 Baltimore, MD 21286 -8334 |
| Contact | David T Krausman |
| Correspondent | David T Krausman INDIVIDUAL MONITORING SYSTEMS, INC. 1055 TAYLOR AVE., SUITE 300 Baltimore, MD 21286 -8334 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-20 |
| Decision Date | 1999-10-15 |
| Summary: | summary |
Trademark Results [ACTITRAC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACTITRAC 75207113 2196406 Dead/Cancelled |
Individual Monitoring Systems, Inc. 1996-12-02 |
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