The following data is part of a premarket notification filed by Persyst Consulting Services, Inc. with the FDA for Persyst Spike Detector.
| Device ID | K950117 |
| 510k Number | K950117 |
| Device Name: | PERSYST SPIKE DETECTOR |
| Classification | Automatic Event Detection Software For Full-montage Electroencephalograph |
| Applicant | PERSYST CONSULTING SERVICES, INC. 605 E ST. Belmar, NJ 07719 |
| Contact | Scott B Wilson |
| Correspondent | Scott B Wilson PERSYST CONSULTING SERVICES, INC. 605 E ST. Belmar, NJ 07719 |
| Product Code | OMB |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-11 |
| Decision Date | 1995-04-05 |