ESSENZ Patient Monitor

Display, Cathode-ray Tube, Medical

LivaNova Deutschland GmbH

The following data is part of a premarket notification filed by Livanova Deutschland Gmbh with the FDA for Essenz Patient Monitor.

Pre-market Notification Details

Device IDK212003
510k NumberK212003
Device Name:ESSENZ Patient Monitor
ClassificationDisplay, Cathode-ray Tube, Medical
Applicant LivaNova Deutschland GmbH Lindberghstr. 25 Munich,  DE 80939
ContactFlorian Goetz
CorrespondentFlorian Goetz
LivaNova Deutschland GmbH Lindberghstr. 25 Munich,  DE 80939
Product CodeDXJ  
CFR Regulation Number870.2450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-28
Decision Date2021-11-10

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