Empatica Health Monitoring Platform
K-Number: K221282 · 2022-11-20
ApplicantEmpatica S.r.l.
Decision Date2022-11-20
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Empatica Health Monitoring Platform is a medical device manufactured by Empatica S.r.l.. It received FDA 510(k) clearance on 2022-11-20 under approval number K221282. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Empatica Health Monitoring Platform?
Empatica Health Monitoring Platform is a medical device that received FDA 510(k) clearance on 2022-11-20. It is manufactured by Empatica S.r.l.. The 510(k) number is K221282.
When was Empatica Health Monitoring Platform approved by the FDA?
Empatica Health Monitoring Platform received FDA 510(k) clearance on 2022-11-20, under approval number K221282.
What company makes Empatica Health Monitoring Platform?
Empatica Health Monitoring Platform is manufactured by Empatica S.r.l..
What is the FDA product code for Empatica Health Monitoring Platform?
The FDA product code for Empatica Health Monitoring Platform is DQA.
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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.