The following data is part of a premarket notification filed by Persyst Development Corp. with the FDA for Persyst Reveal.
| Device ID | K011397 |
| 510k Number | K011397 |
| Device Name: | PERSYST REVEAL |
| Classification | Automatic Event Detection Software For Full-montage Electroencephalograph |
| Applicant | PERSYST DEVELOPMENT CORP. 316 SKYLINE DR. Prescott, AZ 86303 |
| Contact | Scott B Wilson |
| Correspondent | Scott B Wilson PERSYST DEVELOPMENT CORP. 316 SKYLINE DR. Prescott, AZ 86303 |
| Product Code | OMB |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-07 |
| Decision Date | 2001-08-03 |
| Summary: | summary |