Cleared Traditional

K231182 - Thermogard HQ? Temperature Management System, Thermogard XP? Temperature Management System
(FDA 510(k) Clearance)

K231182 · Zoll Circulation, Inc. · Cardiovascular
Nov 2023
Decision
191d
Days
Class 2
Risk

K231182 is an FDA 510(k) clearance for the Thermogard HQ? Temperature Management System, Thermogard XP? Temperature Management System. This device is classified as a Hyperthermia Monitor (Class II — Special Controls, product code NZE).

Submitted by Zoll Circulation, Inc. (San Jose, US). The FDA issued a Cleared decision on November 3, 2023, 191 days after receiving the submission on April 26, 2023.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5900. Intended To Monitor And Reduce A Patient's Temperature To Mild Hypothermia (not To Go Below 32 Degrees Celsius. To Induce Mild Hypothermia In Hyperthermic Patients E.g., Heat Stroke, Fever (excluding Fever Related To Head Injury, Cardiac Arrest, Or Other Severe Medical Conditions)..

Submission Details

510(k) Number K231182 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2023
Decision Date November 03, 2023
Days to Decision 191 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code NZE — Hyperthermia Monitor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5900
Definition Intended To Monitor And Reduce A Patient's Temperature To Mild Hypothermia (not To Go Below 32 Degrees Celsius. To Induce Mild Hypothermia In Hyperthermic Patients E.g., Heat Stroke, Fever (excluding Fever Related To Head Injury, Cardiac Arrest, Or Other Severe Medical Conditions).