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)

ZOLL Arrhythmia Management Sysyem

K-Number: K190939 · 2019-12-19

ApplicantZoll Manufacturing Corporation
Decision Date2019-12-19
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZOLL Arrhythmia Management Sysyem is a medical device manufactured by Zoll Manufacturing Corporation. It received FDA 510(k) clearance on 2019-12-19 under approval number K190939. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZOLL Arrhythmia Management Sysyem?

ZOLL Arrhythmia Management Sysyem is a medical device that received FDA 510(k) clearance on 2019-12-19. It is manufactured by Zoll Manufacturing Corporation. The 510(k) number is K190939.

When was ZOLL Arrhythmia Management Sysyem approved by the FDA?

ZOLL Arrhythmia Management Sysyem received FDA 510(k) clearance on 2019-12-19, under approval number K190939.

What company makes ZOLL Arrhythmia Management Sysyem?

ZOLL Arrhythmia Management Sysyem is manufactured by Zoll Manufacturing Corporation.

What is the FDA product code for ZOLL Arrhythmia Management Sysyem?

The FDA product code for ZOLL Arrhythmia Management Sysyem is MHX.

Related Clinical Trials

NCT07471308 P-wave Duration and Local Potential as Predictors of AF Recurrence Following Pulmonary Vein Isolation ACTIVE_NOT_RECRUITING

Other Devices by Zoll Manufacturing Corporation

K172510µCor Heart Failure and Arrhythmia Management System K182093ZOLL ECG Analysis Software PMA P010030Wearable automated external defibrillator

Related Devices (Code: MHX)

K160981Patient MonitorEdan Instruments, Inc. K153707Nihon Kohden Vital Sign TelemeterNihon Kohden Corporation K160685Surveyor S4 Mobile MonitorMortara Instrument, Inc. K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800Philips Medizin Systeme Boeblingen GmbH K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems

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.

↑