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FDA 510(k)

Disposable Blood Pressure cuff; Reusable Blood Pressure cuff

K-Number: K242623 · 2024-10-31

ApplicantShenzhen Medke Technology Co., Ltd.
Decision Date2024-10-31
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Disposable Blood Pressure cuff; Reusable Blood Pressure cuff is a medical device manufactured by Shenzhen Medke Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-10-31 under approval number K242623. 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 Disposable Blood Pressure cuff; Reusable Blood Pressure cuff?

Disposable Blood Pressure cuff; Reusable Blood Pressure cuff is a medical device that received FDA 510(k) clearance on 2024-10-31. It is manufactured by Shenzhen Medke Technology Co., Ltd.. The 510(k) number is K242623.

When was Disposable Blood Pressure cuff; Reusable Blood Pressure cuff approved by the FDA?

Disposable Blood Pressure cuff; Reusable Blood Pressure cuff received FDA 510(k) clearance on 2024-10-31, under approval number K242623.

What company makes Disposable Blood Pressure cuff; Reusable Blood Pressure cuff?

Disposable Blood Pressure cuff; Reusable Blood Pressure cuff is manufactured by Shenzhen Medke Technology Co., Ltd..

What is the FDA product code for Disposable Blood Pressure cuff; Reusable Blood Pressure cuff?

The FDA product code for Disposable Blood Pressure cuff; Reusable Blood Pressure cuff is DXQ.

Related Clinical Trials

NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT07613762 High-Flow Nasal Cannula on Exercise Tolerance in Heart Failure Patients Undergoing Cardiac Rehabilitation. NOT_YET_RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT07099092 Causal Mechanisms of Odor-Guided Behavior in Humans NOT_YET_RECRUITING NCT07300878 Effect of Video Laryngoscopy Versus Conventional Laryngoscopy Upon Hemodynamics COMPLETED NCT05707806 Development and Validation of Learning and Decision-Making Tasks RECRUITING

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 Shenzhen Medke Technology Co., Ltd.

K152390Medke Oximetry Finger Sensor K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)

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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