FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
EpiMonitor
K Number: K232915
·
Decision Feb 15, 2024
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
9
Applicant Total
8
Review Days
149
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Basic Information
- Device Name
- EpiMonitor
- K Number
- K232915
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1580
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Empatica S.r.l.
- Date Received
- September 19, 2023
- Decision Date
- February 15, 2024
- Product Code
- POS
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| POS | Physiological Signal Based Seizure Monitoring System | FDA class 2 | Neurology |
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Other Clearances by Empatica S.r.l.
| K Number | Device Name | ||
|---|---|---|---|
| K252981 | EmbraceMini | Dec 22, 2025 | Substantially Equivalent |
| K250515 | EpiMonitor | Jun 19, 2025 | Substantially Equivalent |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Jun 6, 2025 | Substantially Equivalent |
| K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Oct 30, 2023 | Substantially Equivalent |
| K221282 | Empatica Health Monitoring Platform | Nov 20, 2022 | Substantially Equivalent |
| K181861 | Embrace | Dec 20, 2018 | Substantially Equivalent |
| K172935 | Embrace | Jan 26, 2018 | Substantially Equivalent |