Embrace
K-Number: K181861 · 2018-12-20
ApplicantEmpatica S.r.l.
Decision Date2018-12-20
Product CodePOS
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Embrace is a medical device manufactured by Empatica S.r.l.. It received FDA 510(k) clearance on 2018-12-20 under approval number K181861. The device is classified under product code POS. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Embrace?
Embrace is a medical device that received FDA 510(k) clearance on 2018-12-20. It is manufactured by Empatica S.r.l.. The 510(k) number is K181861.
When was Embrace approved by the FDA?
Embrace received FDA 510(k) clearance on 2018-12-20, under approval number K181861.
What company makes Embrace?
Embrace is manufactured by Empatica S.r.l..
What is the FDA product code for Embrace?
The FDA product code for Embrace is POS.
Other Devices by Empatica S.r.l.
Related Devices (Code: POS)
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.