FDA 510(k)

LUCAS 3 Chest Compression System

K-Number: K161768 · 2016-11-09

Decision Date2016-11-09

Product CodeDRM

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

LUCAS 3 Chest Compression System is the device name listed in this FDA 510(k) record. The listed applicant is Jolife AB. It received FDA 510(k) clearance on 2016-11-09 under 510(k) number K161768. The device is classified under product code DRM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUCAS 3 Chest Compression System?

LUCAS 3 Chest Compression System is a medical device that received FDA 510(k) clearance on 2016-11-09. The listed applicant is Jolife AB. The 510(k) number is K161768.

When did LUCAS 3 Chest Compression System receive FDA 510(k) clearance?

LUCAS 3 Chest Compression System received FDA 510(k) clearance on 2016-11-09, under 510(k) number K161768.

Who is the listed applicant for LUCAS 3 Chest Compression System?

The FDA 510(k) record lists Jolife AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUCAS 3 Chest Compression System?

The FDA product code for LUCAS 3 Chest Compression System is DRM.

Other records listing Jolife AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173553LUCAS 3 Chest Compression System

Related Devices (Code: DRM)

K221700AutoPulse NXT Resuscitation SystemZoll Circulation, Inc.K211289RMU-2000 Automated Chest Compression SystemDefibtech, LLC K173553LUCAS 3 Chest Compression SystemJolife AB K153628ROSC-U Mini Chest Compressor (RMCC)Resuscitation International, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.