K181861 is an FDA 510(k) clearance for the Embrace. This device is classified as a Physiological Signal Based Seizure Monitoring System (Class II - Special Controls, product code POS).
Submitted by Empatica S.R.L. (Milano, IT). The FDA issued a Cleared decision on December 20, 2018, 161 days after receiving the submission on July 12, 2018.
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 | K181861 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2018 |
| Decision Date | December 20, 2018 |
| Days to Decision | 161 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. |