Search Results
Found 2 results
510(k) Data Aggregation
K Number
K222897Device Name
Enlight 2100
Manufacturer
Timpel S.A.
Date Cleared
2023-03-07
(165 days)
Product Code
QEB, BZK
Regulation Number
868.1505Why did this record match?
Applicant Name (Manufacturer) :
Timpel S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ENLIGHT 2100 is a non-invasive, radiation free 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 an adjunctive tool to other clinical information in order to support the user's assessment of variations in regional air content within a cross section of a patient's thorax.
ENLIGHT 2100 also provides respiratory parameters based on spirometric monitoring.
It is intended for mechanically ventilated adult and pediatric patients in a hospital setting, whose thorax perimeter is within the range of 37.5 - 134 cm.
ENLIGHT 2100 does not measure regional ventilation of the lungs
Device Description
ENLIGHT 2100 is a Ventilatory electrical impedance tomograph that uses several electrodes (usually between 16 and 32) placed around the patient's thorax to assess regional impedance variation in a lung slice (tomography). It provides a relative measurement, so it only provides information on variations in local impedance. ENLIGHT 2100 estimates Local Impedance Variation, occurring in a cross section of the thorax during a respiratory cycle, and which are linearly related to Variations in Regional Air Content within the lung.
Ask a Question
K Number
K211135Device Name
Enlight 2100
Manufacturer
Timpel S.A.
Date Cleared
2022-01-06
(265 days)
Product Code
QEB, OEB
Regulation Number
868.1505Why did this record match?
Applicant Name (Manufacturer) :
Timpel S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ENLIGHT 2100 is a non-invasive, non-radiation medical device that provides information of local impedance variation within a cross-section of a patient's thorax. This information is presented to the clinician user as an adjunctive tool to other clinical information in order to support the user's assessment of variations in regional air content within a cross section of a patient's lungs.
It is intended for mechanically ventilated adult and pediatric patients in a hospital setting, whose thorax perimeter is within the range of 37.5 - 134cm.
ENLIGHT 2100 does not measure regional ventilation of the lungs.
Device Description
ENLIGHT 2100 is a Ventilatory electrical impedance tomograph that uses several electrodes (usually between 16 and 32) placed around the patient's thorax to assess regional impedance variation in a lung slice (tomography). It provides a relative measurement, so it only provides information on variations in local impedance.
ENLIGHT 2100 estimates Local Impedance Variation, occurring in a cross section of the thorax during a respiratory cycles, and which are linearly related to Variations in Regional Air Content within the lung.
Ask a Question
Page 1 of 1