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FDA 510(k)

AViTA Arm Type Blood Pressure Monitor Cuff

K-Number: K250765 · 2025-09-03

ApplicantAvita Corporation
Decision Date2025-09-03
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AViTA Arm Type Blood Pressure Monitor Cuff is a medical device manufactured by Avita Corporation. It received FDA 510(k) clearance on 2025-09-03 under approval number K250765. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AViTA Arm Type Blood Pressure Monitor Cuff?

AViTA Arm Type Blood Pressure Monitor Cuff is a medical device that received FDA 510(k) clearance on 2025-09-03. It is manufactured by Avita Corporation. The 510(k) number is K250765.

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

AViTA Arm Type Blood Pressure Monitor Cuff received FDA 510(k) clearance on 2025-09-03, under approval number K250765.

What company makes AViTA Arm Type Blood Pressure Monitor Cuff?

AViTA Arm Type Blood Pressure Monitor Cuff is manufactured by Avita Corporation.

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

The FDA product code for AViTA Arm Type Blood Pressure Monitor Cuff is DXQ.

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

K180155Arm Type Blood Pressure Monitor 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

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Related Devices (Code: DXQ)

K160530Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure CuffShenzhen Med-Link Electronics Tech Co., Ltd. K161035Medline Singe Patient Use Blood Pressure CuffMedline Industries, Inc. K152006Cogent Hemodynamic Monitoring SystemIcu Medical, Inc. K153251Tenso TS-101S and TS-101D Disposable Blood Pressure CuffNingbo Free Trade Zone Tenso Medical Instruments Co., Ltd. K171889Reusable Blood Pressure CuffSuzhou Minhua Medical Apparatus Supplies Co., Ltd. K173044Reusable Blood Pressure Cuff, Disposable Blood Pressure CuffNingbo Albert Novosino 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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