The following data is part of a premarket notification filed by Persyst Development Corp. with the FDA for Persyst 12 Eeg Review And Analysis Software.
| Device ID | K132306 |
| 510k Number | K132306 |
| Device Name: | PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE |
| Classification | Automatic Event Detection Software For Full-montage Electroencephalograph |
| Applicant | PERSYST DEVELOPMENT CORP. 12625 HIGH BLUFF DRIVE SUITE 213 San Diego, CA 92130 |
| Contact | Dari Darabbeigi |
| Correspondent | Dari Darabbeigi PERSYST DEVELOPMENT CORP. 12625 HIGH BLUFF DRIVE SUITE 213 San Diego, CA 92130 |
| Product Code | OMB |
| Subsequent Product Code | OLT |
| Subsequent Product Code | OMA |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-24 |
| Decision Date | 2013-11-21 |