NEONATE ARRAY COILS

Coil, Magnetic Resonance, Specialty

LMT MEDICAL SYSTEMS GMBH

The following data is part of a premarket notification filed by Lmt Medical Systems Gmbh with the FDA for Neonate Array Coils.

Pre-market Notification Details

Device IDK091047
510k NumberK091047
Device Name:NEONATE ARRAY COILS
ClassificationCoil, Magnetic Resonance, Specialty
Applicant LMT MEDICAL SYSTEMS GMBH OSTERWEIDE 8 Luebeck,  DE 23562
ContactKristina Luetje
CorrespondentKristina Luetje
LMT MEDICAL SYSTEMS GMBH OSTERWEIDE 8 Luebeck,  DE 23562
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-13
Decision Date2010-08-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04260486610216 K091047 000
04260486610599 K091047 000
04260486610940 K091047 000
04260486610957 K091047 000
04260486610377 K091047 000
04260486610612 K091047 000
04260486610636 K091047 000
04260486610230 K091047 000
04260486610629 K091047 000
04260486610155 K091047 000
04260486610209 K091047 000
04260486610582 K091047 000

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