ESSENZ Patient Monitor— 510(k) K212003

Clearance details

Applicant

Livanova Deutschland, GmbH

Product code

Code DXJ

Device class

Class 2

Regulation

21 CFR 870.2450

Advisory panel

Cardiovascular

Date received

2021-06-28

Decision date

2021-11-10

Decision

Substantially Equivalent

Clearance type

Special

Location

Munich, DE

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• K232291 — Essenz HLM, Essenz ILBM2023-08-24
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• K220635 — Heater-Cooler System 3T2022-11-16
• K210130 — Stockert S5 System2021-04-05
• K202154 — B-Capta2021-04-01

Death

2

Total

2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →