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FDA 510(k)

AUTOPULSE RESUSCITATION SYSTEM MODEL100

K-Number: K063602 · 2006-12-21

ApplicantZoll Circulation
Decision Date2006-12-21
Product CodeDRM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AUTOPULSE RESUSCITATION SYSTEM MODEL100 is the device name listed in this FDA 510(k) record. The listed applicant is Zoll Circulation. It received FDA 510(k) clearance on 2006-12-21 under 510(k) number K063602. 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 AUTOPULSE RESUSCITATION SYSTEM MODEL100?

AUTOPULSE RESUSCITATION SYSTEM MODEL100 is a medical device that received FDA 510(k) clearance on 2006-12-21. The listed applicant is Zoll Circulation. The 510(k) number is K063602.

When did AUTOPULSE RESUSCITATION SYSTEM MODEL100 receive FDA 510(k) clearance?

AUTOPULSE RESUSCITATION SYSTEM MODEL100 received FDA 510(k) clearance on 2006-12-21, under 510(k) number K063602.

Who is the listed applicant for AUTOPULSE RESUSCITATION SYSTEM MODEL100?

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

What is the FDA product code for AUTOPULSE RESUSCITATION SYSTEM MODEL100?

The FDA product code for AUTOPULSE RESUSCITATION SYSTEM MODEL100 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 Zoll Circulation 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.

K112998AUTOPULSE RESUSCITATION SYSTEM MODEL 1000K101987COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593K072527AUTOPULSE RESUSCITATION SYSTEM, MODEL 100

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

View on FDA Database →

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

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