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FDA 510(k)

physiQ Heart Rhythm Module

K-Number: K180234 · 2018-08-10

ApplicantPhysiq, Inc.
Decision Date2018-08-10
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

physiQ Heart Rhythm Module is a medical device manufactured by Physiq, Inc.. It received FDA 510(k) clearance on 2018-08-10 under approval number K180234. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the physiQ Heart Rhythm Module?

physiQ Heart Rhythm Module is a medical device that received FDA 510(k) clearance on 2018-08-10. It is manufactured by Physiq, Inc.. The 510(k) number is K180234.

When was physiQ Heart Rhythm Module approved by the FDA?

physiQ Heart Rhythm Module received FDA 510(k) clearance on 2018-08-10, under approval number K180234.

What company makes physiQ Heart Rhythm Module?

physiQ Heart Rhythm Module is manufactured by Physiq, Inc..

What is the FDA product code for physiQ Heart Rhythm Module?

The FDA product code for physiQ Heart Rhythm Module is DPS.

Related Clinical Trials

NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT07601763 Pulsed Field Ablation Outcomes With Efficacy and Randomization in Atrial Fibrillation (POWER-AF) RECRUITING NCT06164808 Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch RECRUITING NCT06299514 RAFT - Pace &Ablate RECRUITING NCT05229211 Tracking Atrial Fibrillation After Intensive Care Admission ACTIVE_NOT_RECRUITING NCT07572253 A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial Fibrillation NOT_YET_RECRUITING

Other Devices by Physiq, Inc.

K183322physIQ Heart Rhythm and Respiratory Module K193415physIQ Heart Rhythm and Respiration Module

Related Devices (Code: DPS)

K160746CARDIOLINE touchECGCardioline S.P.A K160840ECG100+, ECG200+Cardioline S.P.A K152135Quantitative Electrocardiographic Detector (QED 2000)Acme Portable Machines, Inc. K161302PC ECGEdan Instruments, Inc. K152863Portable ECG MonitorContec Medical Systems Co.,Ltd K152043Diagnostic Station DS20Schiller AG

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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