LUCAS 3 Chest Compression System

Compressor, Cardiac, External

Jolife AB

The following data is part of a premarket notification filed by Jolife Ab with the FDA for Lucas 3 Chest Compression System.

Pre-market Notification Details

Device IDK173553
510k NumberK173553
Device Name:LUCAS 3 Chest Compression System
ClassificationCompressor, Cardiac, External
Applicant Jolife AB Scheelevagen 17 Ideon Science Park Lund,  SE 22370
ContactMalin Melander
CorrespondentJohn J. Smith
Hogan Lovells US LLP 555 Thirteenth Street NW Washington,  DC  20004
Product CodeDRM  
CFR Regulation Number870.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-16
Decision Date2018-02-08
Summary:summary

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