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)

AutoPulse NXT Resuscitation System

K-Number: K221700 · 2023-03-09

ApplicantZoll Circulation, Inc.
Decision Date2023-03-09
Product CodeDRM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AutoPulse NXT Resuscitation System is a medical device manufactured by Zoll Circulation, Inc.. It received FDA 510(k) clearance on 2023-03-09 under approval number K221700. 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 NXT Resuscitation System?

AutoPulse NXT Resuscitation System is a medical device that received FDA 510(k) clearance on 2023-03-09. It is manufactured by Zoll Circulation, Inc.. The 510(k) number is K221700.

When was AutoPulse NXT Resuscitation System approved by the FDA?

AutoPulse NXT Resuscitation System received FDA 510(k) clearance on 2023-03-09, under approval number K221700.

What company makes AutoPulse NXT Resuscitation System?

AutoPulse NXT Resuscitation System is manufactured by Zoll Circulation, Inc..

What is the FDA product code for AutoPulse NXT Resuscitation System?

The FDA product code for AutoPulse NXT Resuscitation System is DRM.

Related Clinical Trials

NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING NCT06201429 A Multi-center, Early Feasibility Study of Using the Mechanical Tissue Resuscitation™ (MTR®) Therapy System for Removal of Excess Fluid in Subjects Who Have Had a Portion of Their Skull Removed to Expose the Dura/Brain and Require Drainage for Fluid Removal. RECRUITING NCT07189182 Clinical Evaluation of the Origin Intubation System NOT_YET_RECRUITING NCT06530433 Enhanced Community First Responder System Evaluation in Singapore RECRUITING NCT06998784 Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Acute Pancreatitis COMPLETED

Other Devices by Zoll Circulation, Inc.

K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console K220008Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console K231182Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System K223746Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console K250979Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad)

View all 8 devices →

Related Devices (Code: DRM)

K161768LUCAS 3 Chest Compression SystemJolife AB K153628ROSC-U Mini Chest Compressor (RMCC)Resuscitation International, LLC K173553LUCAS 3 Chest Compression SystemJolife AB K211289RMU-2000 Automated Chest Compression SystemDefibtech, LLC

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.

↑