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ENLIGHT 1810

Timpel S/A · Model TP-ENU00-0 · UDI-DI 07898959841415

QEB Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

"ENLIGHT 1810 is a non-invasive and non-radiation medical device that provides information from impedance variation from a cross-section of a patient’s thorax. This information is presented to the clinician user as adjunctive tool to be used with other clinical information to assess the patient’s ventilation. It is intended for mechanically ventilated adult patients in a hospital setting, whose thorax perimeter is within the range of 78-122 cm. ENLIGHT1810 and its accessories are prescription use only."

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.