The following data is part of a premarket notification filed by Persyst Development Corporation with the FDA for Persyst Mobile App.
| Device ID | K171184 |
| 510k Number | K171184 |
| Device Name: | Persyst Mobile App |
| Classification | Automatic Event Detection Software For Full-montage Electroencephalograph |
| Applicant | Persyst Development Corporation 420 Stevens Avenue Suite 210 Solana Beach, CA 92075 |
| Contact | Dari Darabbeigi |
| Correspondent | Dari Darabbeigi Persyst Development Corporation 420 Stevens Avenue Suite 210 Solana Beach, CA 92075 |
| 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 | 2017-04-24 |
| Decision Date | 2017-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869732000142 | K171184 | 000 |
| 00869732000135 | K171184 | 000 |