The following data is part of a premarket notification filed by Pascall Systems Inc with the FDA for Wireless Eeg System.
| Device ID | K213299 |
| 510k Number | K213299 |
| Device Name: | Wireless EEG System |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | Pascall Systems Inc 200 Portland St Boston, MA 02114 |
| Contact | Tuan Le Mau |
| Correspondent | Robert Steurer Steurer Consulting Group 800 Blue Quail Rd. Keller, TX 76248 |
| Product Code | OLT |
| Subsequent Product Code | GXY |
| Subsequent Product Code | OMC |
| Subsequent Product Code | ORT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-01 |
| Decision Date | 2022-05-11 |