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FDA 510(k)

iHealth Track Blood Pressure Monitor

K-Number: K160014 · 2016-02-02

ApplicantAndon Health Co, Ltd.
Decision Date2016-02-02
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

iHealth Track Blood Pressure Monitor is a medical device manufactured by Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2016-02-02 under approval number K160014. 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 iHealth Track Blood Pressure Monitor?

iHealth Track Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2016-02-02. It is manufactured by Andon Health Co, Ltd.. The 510(k) number is K160014.

When was iHealth Track Blood Pressure Monitor approved by the FDA?

iHealth Track Blood Pressure Monitor received FDA 510(k) clearance on 2016-02-02, under approval number K160014.

What company makes iHealth Track Blood Pressure Monitor?

iHealth Track Blood Pressure Monitor is manufactured by Andon Health Co, Ltd..

What is the FDA product code for iHealth Track Blood Pressure Monitor?

The FDA product code for iHealth Track Blood Pressure Monitor is DXN.

Related Clinical Trials

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025)

Other Devices by Andon Health Co, Ltd.

K153286iHealth Align Gluco-Monitoring system K153278Wireless Smart Gluco-Monitoring System K160565Fully Automatic Electronic Blood Pressure Monitor K160563Fully Automatic Electronic Blood Pressure Monitor K170231iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5) K171062BP5S Wireless Blood Pressure Monitor

View all 31 devices →

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.

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