Embrace
FDA 510(k) clearance K181861 · decided 2018-12-20
Clearance details
- K-number
- K181861
- Device name
- Embrace
- Applicant
- Empatica S.r.l.
- Decision
- Substantially Equivalent
- Date received
- 2018-07-12
- Decision date
- 2018-12-20
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- POS
- Device class
- 2
- Regulation number
- 882.1580
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Milano, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age recall (Z-0159-2024) | EMPATICA SRL | 2023-10-24 |