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)

Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System

K-Number: K231182 · 2023-11-03

ApplicantZoll Circulation, Inc.
Decision Date2023-11-03
Product CodeNZE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System is a medical device manufactured by Zoll Circulation, Inc.. It received FDA 510(k) clearance on 2023-11-03 under approval number K231182. The device is classified under product code NZE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System?

Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System is a medical device that received FDA 510(k) clearance on 2023-11-03. It is manufactured by Zoll Circulation, Inc.. The 510(k) number is K231182.

When was Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System approved by the FDA?

Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System received FDA 510(k) clearance on 2023-11-03, under approval number K231182.

What company makes Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System?

Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System is manufactured by Zoll Circulation, Inc..

What is the FDA product code for Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System?

The FDA product code for Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System is NZE.

Related Clinical Trials

NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING NCT05174312 Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) COMPLETED NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED

Related PubMed Literature

PMID: 32459382 Safety Assessment of an A-Scan Ultrasonic System for Ophthalmic Use. Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine (2020)

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 K221700AutoPulse NXT Resuscitation 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: NZE)

K162523The IQool SystemBraincool AB K250979Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad)Zoll Circulation, Inc. K240933CarbonCool® SystemGlobal Healthcare SG Sdn. Bhd

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.

↑