Cleared Traditional

Empatica Health Monitoring Platform

K221282 · Empatica S.R.L. · Anesthesiology
Nov 2022
Decision
201d
Days
Class 2
Risk

About This 510(k) Submission

K221282 is an FDA 510(k) clearance for the Empatica Health Monitoring Platform, a Oximeter (Class II — Special Controls, product code DQA), submitted by Empatica S.R.L. (Milan, IT). The FDA issued a Cleared decision on November 20, 2022, 201 days after receiving the submission on May 3, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K221282 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 2022
Decision Date November 20, 2022
Days to Decision 201 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DQA — Oximeter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700

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