Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
K-Number: K230457 · 2023-10-30
ApplicantEmpatica S.r.l.
Decision Date2023-10-30
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal is a medical device manufactured by Empatica S.r.l.. It received FDA 510(k) clearance on 2023-10-30 under approval number K230457. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal?
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal is a medical device that received FDA 510(k) clearance on 2023-10-30. It is manufactured by Empatica S.r.l.. The 510(k) number is K230457.
When was Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal approved by the FDA?
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal received FDA 510(k) clearance on 2023-10-30, under approval number K230457.
What company makes Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal?
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal is manufactured by Empatica S.r.l..
What is the FDA product code for Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal?
The FDA product code for Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal is MWI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.