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FDA 510(k)

Accurate 24 Non-invasive blood pressure monitor

K-Number: K222658 · 2023-06-21

ApplicantAccurate Meditech, Inc.
Decision Date2023-06-21
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Accurate 24 Non-invasive blood pressure monitor is the device name listed in this FDA 510(k) record. The listed applicant is Accurate Meditech, Inc.. It received FDA 510(k) clearance on 2023-06-21 under 510(k) number K222658. 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 Accurate 24 Non-invasive blood pressure monitor?

Accurate 24 Non-invasive blood pressure monitor is a medical device that received FDA 510(k) clearance on 2023-06-21. The listed applicant is Accurate Meditech, Inc.. The 510(k) number is K222658.

When did Accurate 24 Non-invasive blood pressure monitor receive FDA 510(k) clearance?

Accurate 24 Non-invasive blood pressure monitor received FDA 510(k) clearance on 2023-06-21, under 510(k) number K222658.

Who is the listed applicant for Accurate 24 Non-invasive blood pressure monitor?

The FDA 510(k) record lists Accurate Meditech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Accurate 24 Non-invasive blood pressure monitor?

The FDA product code for Accurate 24 Non-invasive blood pressure monitor is DXN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07510451The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic SurgeryRECRUITINGNCT06292299The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility StudyRECRUITING

Related PubMed Literature

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMID: 40388896Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates.Neonatology (2025)

Other records listing Accurate Meditech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)

Related Devices (Code: DXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261061BP Go (BPP-855)Wellvii, Inc.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)Guangzhou Daxin Health Technology Co., Ltd.K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife CorporationK253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.K260693VicorderCS (VCS-SYS-1100)80 Beats Medical GmbH

Official Source

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