K243515 is an FDA 510(k) clearance for the EpiWatch Monitoring System. This device is classified as a Physiological Signal Based Seizure Monitoring System (Class II - Special Controls, product code POS).
Submitted by Epiwatch, Inc. (Baltimore, US). The FDA issued a Cleared decision on March 7, 2025, 114 days after receiving the submission on November 13, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1580. The Physiological Signal Based Seizure Monitoring System Is A Prescription Device That Uses Physiological Signal To Identify Abnormal Physiological Activity That May Be Associated With A Seizure. The System Does Not Predict Seizure Onsets, And Is Not Intended As A Standalone Seizure Monitoring Device..
| 510(k) Number | K243515 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2024 |
| Decision Date | March 07, 2025 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | POS - Physiological Signal Based Seizure Monitoring System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1580 |
| Definition | The Physiological Signal Based Seizure Monitoring System Is A Prescription Device That Uses Physiological Signal To Identify Abnormal Physiological Activity That May Be Associated With A Seizure. The System Does Not Predict Seizure Onsets, And Is Not Intended As A Standalone Seizure Monitoring Device. |