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)

HRVWatch-Mini Wrist Monitor

K-Number: K201914 · 2021-06-07

ApplicantTaiwan Scientific Corporation
Decision Date2021-06-07
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HRVWatch-Mini Wrist Monitor is a medical device manufactured by Taiwan Scientific Corporation. It received FDA 510(k) clearance on 2021-06-07 under approval number K201914. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HRVWatch-Mini Wrist Monitor?

HRVWatch-Mini Wrist Monitor is a medical device that received FDA 510(k) clearance on 2021-06-07. It is manufactured by Taiwan Scientific Corporation. The 510(k) number is K201914.

When was HRVWatch-Mini Wrist Monitor approved by the FDA?

HRVWatch-Mini Wrist Monitor received FDA 510(k) clearance on 2021-06-07, under approval number K201914.

What company makes HRVWatch-Mini Wrist Monitor?

HRVWatch-Mini Wrist Monitor is manufactured by Taiwan Scientific Corporation.

What is the FDA product code for HRVWatch-Mini Wrist Monitor?

The FDA product code for HRVWatch-Mini Wrist Monitor is DXN.

Related Clinical Trials

NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT07588659 Retail-Grade Weighted Blanket Effectiveness on ADHD-related Sleep Disturbances (BEAD) NOT_YET_RECRUITING NCT05072483 Natural History Study of CADASIL RECRUITING NCT02543983 Neurobiology of Suicide RECRUITING NCT07362303 Neuralert Stroke Monitor Trial RECRUITING

Related Devices (Code: DXN)

K162092Evolv Model BP7000 Upper Arm Blood Pressure MonitorOmron Healthcare, Inc. K161708Arm automatic blood pressure monitorShenzhen Pump Medical System Co., Ltd. K162230Fully Automatic Electronic Blood Pressure MonitorAdon Health Co., Ltd. K160349Electronic SphygmomanometerGuangdong Biolight Meditech Co., Ltd. K161846Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited K161886Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure DeviceGuangdong Transtek Medical Electronics Co., Ltd.

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.

↑