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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Empatica S.r.l.. It received FDA 510(k) clearance on 2018-12-20 under 510(k) 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. The listed applicant is Empatica S.r.l.. The 510(k) number is K181861.

When did Embrace receive FDA 510(k) clearance?

Embrace received FDA 510(k) clearance on 2018-12-20, under 510(k) number K181861.

Who is the listed applicant for Embrace?

The FDA 510(k) record lists Empatica S.r.l. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Embrace?

The FDA product code for Embrace is POS.

Other records listing Empatica S.r.l. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care PortalK252981EmbraceMiniK250515EpiMonitorK242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalK232915EpiMonitorK230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal

View all 9 devices →

Related Devices (Code: POS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251506Nelli (Version 7.11)Neuro Event Labs OYK243199NightWatch+ USLivassured BVK250515EpiMonitorEmpatica S.r.l.K243515EpiWatch Monitoring SystemEpiwatch, Inc.K232915EpiMonitorEmpatica S.r.l.K200276SPEAC SystemBrain Sentinel, Inc.

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.

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