Empatica Health Monitoring Platform

Oximeter

Empatica S.r.l.

The following data is part of a premarket notification filed by Empatica S.r.l. with the FDA for Empatica Health Monitoring Platform.

Pre-market Notification Details

Device IDK221282
510k NumberK221282
Device Name:Empatica Health Monitoring Platform
ClassificationOximeter
Applicant Empatica S.r.l. Via Stendhal, 36 Milan,  IT 20144
ContactAlberto Poli
CorrespondentAlberto Poli
Empatica S.r.l. Via Stendhal, 36 Milan,  IT 20144
Product CodeDQA  
Subsequent Product CodeDRG
Subsequent Product CodeFLL
Subsequent Product CodeGZO
Subsequent Product CodeLEL
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-03
Decision Date2022-11-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00853858006263 K221282 000
00853858006256 K221282 000
00853858006249 K221282 000
00853858006232 K221282 000

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