FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
K Number: K230457
·
Decision Oct 30, 2023
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
305
Applicant Total
8
Review Days
251
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Basic Information
- Device Name
- Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
- K Number
- K230457
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Empatica S.r.l.
- Date Received
- February 21, 2023
- Decision Date
- October 30, 2023
- Product Code
- MWI
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
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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 |
| K232915 | EpiMonitor | Feb 15, 2024 | 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 |