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)

physIQ Heart Rhythm and Respiration Module

K-Number: K193415 · 2020-06-11

ApplicantPhysiq, Inc.
Decision Date2020-06-11
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

physIQ Heart Rhythm and Respiration Module is a medical device manufactured by Physiq, Inc.. It received FDA 510(k) clearance on 2020-06-11 under approval number K193415. 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 and Respiration Module?

physIQ Heart Rhythm and Respiration Module is a medical device that received FDA 510(k) clearance on 2020-06-11. It is manufactured by Physiq, Inc.. The 510(k) number is K193415.

When was physIQ Heart Rhythm and Respiration Module approved by the FDA?

physIQ Heart Rhythm and Respiration Module received FDA 510(k) clearance on 2020-06-11, under approval number K193415.

What company makes physIQ Heart Rhythm and Respiration Module?

physIQ Heart Rhythm and Respiration Module is manufactured by Physiq, Inc..

What is the FDA product code for physIQ Heart Rhythm and Respiration Module?

The FDA product code for physIQ Heart Rhythm and Respiration 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 NCT05664854 Electrical Impedance Tomography & Selective Stimulation of Vagus Nerve RECRUITING NCT06299514 RAFT - Pace &Ablate RECRUITING NCT05229211 Tracking Atrial Fibrillation After Intensive Care Admission ACTIVE_NOT_RECRUITING

Other Devices by Physiq, Inc.

K180234physiQ Heart Rhythm Module K183322physIQ Heart Rhythm and Respiratory 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.

↑