FDA.report

510(k) K221282

Device
Empatica Health Monitoring Platform
Applicant
Empatica S.r.l.
510(k) number
K221282
Product code
DQA  
Decision
Substantially Equivalent (SESE)
Decision date
2022-11-20
Date received
2022-05-03
Regulation
870.2700
Classification name
Oximeter
Medical specialty
Cardiovascular
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Alberto Poli
Address
Via Stendhal, 36 Milan IT 20144 20144

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00853858006263Empatica Health Monitoring PlatformEMPATICA SRL2022-11-24
00853858006256Empatica Health Monitoring PlatformEMPATICA SRL2022-11-24
00853858006249Empatica Health Monitoring PlatformEMPATICA SRL2022-11-24
00853858006232Empatica Health Monitoring PlatformEMPATICA SRL2022-11-24

Legacy Summary

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FDA Review

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