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K Number
K221212
Device Name
Upper Arm Blood Pressure Monitor
Manufacturer
Shenzhen Yolanda Technology Co., Ltd
Date Cleared
2022-08-26

(121 days)

Product Code
DXN
Regulation Number
870.1130
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Upper Arm Blood pressure Monitor a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the arm of which the circumference includes 22 cm-32 cm. It is intended to be used in hospital environment or at home.

Device Description

Upper Arm Blood pressure Monitor, Model SP10A

AI/ML Overview

The provided text is a U.S. FDA 510(k) clearance letter for an "Upper Arm Blood Pressure Monitor, Model SP10A." It does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance), or training set information.

Instead, the document primarily focuses on:

  • Substantial Equivalence: The FDA's determination that the device is substantially equivalent to legally marketed predicate devices.
  • Regulatory Information: References to applicable regulations (e.g., 21 CFR 870.1130 for noninvasive blood pressure measurement systems), general controls, and other requirements.
  • Indications for Use: Describes the intended use of the device for measuring diastolic and systolic blood pressure and pulse rate in adults using an oscillometric technique, for use in hospital or home environments.
  • Type of Use: Specifies that it is intended for Over-The-Counter Use.

To answer your request, a different type of document, such as a summary of safety and effectiveness, clinical study report, or specific test results, would be needed. The current document does not provide the detailed performance and study information you're asking for.

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).