510(k) K221282

Empatica Health Monitoring Platform by Empatica S.r.l. — Product Code DQA

K221282 is an FDA 510(k) premarket notification submitted by Empatica S.r.l. for the device "Empatica Health Monitoring Platform". The FDA issued a decision of Substantially Equivalent on November 20, 2022. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Empatica S.r.l. has at least 7 other 510(k) clearances on record.