Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LUCAS 3 Chest Compression System

K-Number: K161768 · 2016-11-09

ApplicantJolife AB
Decision Date2016-11-09
Product CodeDRM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LUCAS 3 Chest Compression System is a medical device manufactured by Jolife AB. It received FDA 510(k) clearance on 2016-11-09 under approval 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. It is manufactured by Jolife AB. The 510(k) number is K161768.

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

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

What company makes LUCAS 3 Chest Compression System?

LUCAS 3 Chest Compression System is manufactured by Jolife AB.

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

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

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT07609511 Magnet System Gastric Outlet Obstruction Study NOT_YET_RECRUITING NCT07603531 Assessment of the Efficacy of the Dynamic Decongestive System in the Maintenance Phase of Lower Limb Lymphedema NOT_YET_RECRUITING NCT07373496 Patient Position Monitoring System for Beam Gated Radiation Therapy of Malignancies of the Chest and Upper Abdomen RECRUITING NCT07600489 A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers NOT_YET_RECRUITING

Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024)

Other Devices by Jolife AB

K173553LUCAS 3 Chest Compression System

Related Devices (Code: DRM)

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

Official Source

View on FDA Database →

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

↑