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510(k) Data Aggregation
K Number
K062052Device Name
LMT NOMAG IC 3.0
Manufacturer
LMT LAMMERS MEDICAL TECHNOLOGY GMBH
Date Cleared
2006-07-31
(11 days)
Product Code
FPL
Regulation Number
880.5410Why did this record match?
Applicant Name (Manufacturer) :
LMT LAMMERS MEDICAL TECHNOLOGY GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LMT nomag IC 3.0 MR-incubator is an infant incubator system for temporary use during MR-imaging in clinical environments provided with a suitable trolley for intra hospital transport.
The LMT nomag IC 3.0 MR-incubator provides a controlled environment of warmth and humidity for premature babies and sick infants up to a body weight of 4.5 kg (10 lbs) and a maximum body length of 55 cm (21.7 inches).
The LMT nomag IC 3.0 is suitable for use with MR scanners of field strengths up to 3.0T.
Device Description
The LMT Nomag IC 3.0 is an incubator for preterm and term-born infants who are scheduled for Magnetic Resonance (MR) Imaging and are dependant on warming therapy. It provides a microclimate of air temperature and humidity suiting the infants needs. The incubator has a trolley for intra clinical transport providing power.
The incubator runs in air control mode and has closed loop control for both air temperature and humidity. Humidification works hygienically via vaporizing of distilled water.
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K Number
K033565Device Name
LMT NOMAG IC 1,5
Manufacturer
LMT LAMMERS MEDICAL TECHNOLOGY GMBH
Date Cleared
2003-11-21
(9 days)
Product Code
FPL
Regulation Number
880.5410Why did this record match?
Applicant Name (Manufacturer) :
LMT LAMMERS MEDICAL TECHNOLOGY GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LMT nomag IC 1,5 is an infant incubator system for temporary use during MR-imaging in clinical environments and in combination with a suitable trolley for intra hospital transport.
LMT nomag IC 1,5 provides a controlled environment of warmth and humidity for premature babies and sick infants up to a body weight of 4,5 kg (10 lbs) and a maximum body length of 55 cm (21.7 inches).
LMT nomag IC 1,5 is suitable for MR scanner of field strengths up to 1.5T.
Device Description
The LMT Nomag IC 1,5 is an incubator for preterm and term-born infants who are scheduled for Magnetic Resonance (MR) Imaging and are dependant on warming therapv. It provides a microclimate of air temperature and humidity suiting the infants needs. The incubator has a trolley for intra clinical transport providing power.
The incubator runs in air control mode and has closed loop control for both air temperature and humiditication works hygienically via vaporizing of distilled water.
Ask a Question
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