LUCAS 3 Chest Compression System

FDA 510(k) K161768 · Jolife AB

Substantially Equivalent

510(k) numberK161768

Submission

Device name
LUCAS 3 Chest Compression System
Applicant
Jolife AB
Lund, SE
Received
June 27, 2016
Decision date
November 9, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DRM – Compressor, Cardiac, External
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5200
Specialty
Cardiovascular

Other 510(k)s with product code DRM

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K221700AutoPulse NXT Resuscitation SystemDRM · Traditional Zoll Circulation, Inc.03/09/2023SE
K211289RMU-2000 Automated Chest Compression SystemDRM · Traditional Defibtech, LLC11/09/2021SE
K173553LUCAS 3 Chest Compression SystemDRM · Traditional Jolife AB02/08/2018SE
K153628ROSC-U Mini Chest Compressor (RMCC)DRM · Traditional Resuscitation International, LLC01/30/2016SE
K141809RMU-1000 Automated Chest Compression SystemDRM · Traditional Defibtech, LLC10/27/2014SE
K112998Autopulse Resuscitation System Model 1000DRM · Traditional Zoll Circulation03/15/2012SE
K102068Miniaturize Chest Compressor (MCC)DRM · Traditional Resuscitation International11/16/2010SE
K090422Lucas 2DRM · Traditional Jolife AB06/17/2009SE
K072527Autopulse Resuscitation System, Model 100DRM · Traditional Zoll Circulation03/19/2008SE
K073079Thumper, Model: 1008DRM · Traditional Michigan Instruments, Inc.02/14/2008SE

More from Michigan Instruments, Inc.

510(k)DeviceDecision
K173553LUCAS 3 Chest Compression SystemDRM · Traditional 02/08/2018SE
K090422Lucas 2DRM · Traditional 06/17/2009SE
K062401Modification to LucasDRM · Traditional 09/28/2006SE
K053403LucasDRM · Traditional 02/01/2006SE

Questions and answers

When was LUCAS 3 Chest Compression System cleared by the FDA?

LUCAS 3 Chest Compression System (K161768) received a 510(k) decision of Substantially Equivalent on November 9, 2016, 135 days after the submission was received.

What is the product code of K161768?

The FDA product code is DRM – Compressor, Cardiac, External, a Class II (moderate risk) device regulated under 21 CFR 870.5200.