Cleared Traditional

Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal

K230457 · Empatica S.R.L. · Cardiovascular

Oct 2023

Decision

251d

Days

Class 2

Risk

About This 510(k) Submission

K230457 is an FDA 510(k) clearance for the Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal, a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI), submitted by Empatica S.R.L. (Milan, IT). The FDA issued a Cleared decision on October 30, 2023, 251 days after receiving the submission on February 21, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K230457 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 21, 2023
Decision Date	October 30, 2023
Days to Decision	251 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2300