The following data is part of a premarket notification filed by Cadwell with the FDA for Cadwell Spike And Seizure Detector.
| Device ID | K140552 |
| 510k Number | K140552 |
| Device Name: | CADWELL SPIKE AND SEIZURE DETECTOR |
| Classification | Automatic Event Detection Software For Full-montage Electroencephalograph |
| Applicant | CADWELL 909 N. KELLOGG ST. Kennewick, WA 99336 |
| Contact | Jinesh Jain |
| Correspondent | Jinesh Jain CADWELL 909 N. KELLOGG ST. Kennewick, WA 99336 |
| Product Code | OMB |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-04 |
| Decision Date | 2014-07-23 |
| Summary: | summary |