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FDA 510(k)

MODIFICATION TO LUCAS

K-Number: K062401 · 2006-09-28

ApplicantJolife AB
Decision Date2006-09-28
Product CodeDRM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO LUCAS is the device name listed in this FDA 510(k) record. The listed applicant is Jolife AB. It received FDA 510(k) clearance on 2006-09-28 under 510(k) number K062401. 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 MODIFICATION TO LUCAS?

MODIFICATION TO LUCAS is a medical device that received FDA 510(k) clearance on 2006-09-28. The listed applicant is Jolife AB. The 510(k) number is K062401.

When did MODIFICATION TO LUCAS receive FDA 510(k) clearance?

MODIFICATION TO LUCAS received FDA 510(k) clearance on 2006-09-28, under 510(k) number K062401.

Who is the listed applicant for MODIFICATION TO LUCAS?

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 MODIFICATION TO LUCAS?

The FDA product code for MODIFICATION TO LUCAS is DRM.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SystemK161768LUCAS 3 Chest Compression SystemK090422LUCAS 2K053403LUCAS

Related Devices (Code: DRM)

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.

K221700AutoPulse NXT Resuscitation SystemZoll Circulation, Inc.K211289RMU-2000 Automated Chest Compression SystemDefibtech, LLCK173553LUCAS 3 Chest Compression SystemJolife ABK161768LUCAS 3 Chest Compression SystemJolife ABK153628ROSC-U Mini Chest Compressor (RMCC)Resuscitation International, LLCK112998AUTOPULSE RESUSCITATION SYSTEM MODEL 1000Zoll Circulation

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.

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