Seca Medical Vital Signs Analyzer 535, Seca MVSA 535, Seca MVSA, Seca 535

System, Measurement, Blood-pressure, Non-invasive

Seca GmbH & Co. Kg

The following data is part of a premarket notification filed by Seca Gmbh & Co. Kg with the FDA for Seca Medical Vital Signs Analyzer 535, Seca Mvsa 535, Seca Mvsa, Seca 535.

Pre-market Notification Details

Device IDK192092
510k NumberK192092
Device Name:Seca Medical Vital Signs Analyzer 535, Seca MVSA 535, Seca MVSA, Seca 535
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Seca GmbH & Co. Kg Hammer Steindamm 3-25 Hamburg,  DE 22089
ContactCorinna Hatje
CorrespondentOliver Eikenberg
Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin,  TX  78746
Product CodeDXN  
Subsequent Product CodeDQA
Subsequent Product CodeFLL
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-05
Decision Date2020-01-23

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