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FDA 510(k)

Arm Type Blood Pressure Monitor

K-Number: K180155 · 2018-08-03

ApplicantAvita Corporation
Decision Date2018-08-03
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Arm Type Blood Pressure Monitor is a medical device manufactured by Avita Corporation. It received FDA 510(k) clearance on 2018-08-03 under approval number K180155. 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 Arm Type Blood Pressure Monitor?

Arm Type Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2018-08-03. It is manufactured by Avita Corporation. The 510(k) number is K180155.

When was Arm Type Blood Pressure Monitor approved by the FDA?

Arm Type Blood Pressure Monitor received FDA 510(k) clearance on 2018-08-03, under approval number K180155.

What company makes Arm Type Blood Pressure Monitor?

Arm Type Blood Pressure Monitor is manufactured by Avita Corporation.

What is the FDA product code for Arm Type Blood Pressure Monitor?

The FDA product code for Arm Type 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: 41623865 Case Report: Hypertensive encephalopathy presents with complex types of sleep breathing events. Frontiers in cardiovascular medicine (2025)

Other Devices by Avita Corporation

K172427AViTA Radar Thermo NT16 Series IR Thermometer K200346Wrist Type Blood Pressure Monitor K241852Nasal Aspirator (NS 13) K242193Arm Type Blood Pressure Monitor (BPM82) K223399AViTA Pulse Oximeter K250765AViTA Arm Type Blood Pressure Monitor Cuff

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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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