Embrace— 510(k) K181861

Substantially Equivalent

Empatica S.r.l.

FDA 510(k) clearance K181861 for Embrace, Substantially Equivalent on 2018-12-20. Applicant: Empatica S.r.l.. Device class: 2.

Clearance details

Applicant: Empatica S.r.l.
Product code: Code POS
Device class: Class 2
Regulation: 21 CFR 882.1580
Advisory panel: Neurology
Date received: 2018-07-12
Decision date: 2018-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milano, IT

Download summary PDF View on FDA.gov ↗

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More clearances from Empatica S.r.l.

Recalls naming K181861

K-number listed on FDA's recall record

Z-0159-2024 — Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-SClass II·Ongoing·EMPATICA SRL·20230713

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181861.

Data sourced from openFDA. This site is unofficial and independent of the FDA.