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FDA 510(k)

Empatica Health Monitoring Platform

K-Number: K221282 · 2022-11-20

Decision Date2022-11-20
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Empatica Health Monitoring Platform 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 2022-11-20 under 510(k) 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. The listed applicant is Empatica S.r.l.. The 510(k) number is K221282.

When did Empatica Health Monitoring Platform receive FDA 510(k) clearance?

Empatica Health Monitoring Platform received FDA 510(k) clearance on 2022-11-20, under 510(k) number K221282.

Who is the listed applicant for Empatica Health Monitoring Platform?

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 Empatica Health Monitoring Platform?

The FDA product code for Empatica Health Monitoring Platform is DQA.

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.

View all 9 devices →

Related Devices (Code: DQA)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.