ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4000

• K Number: K964153
• Device Name: ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4000
• Manufacturer: ROSSMAX INTERNATIONAL LTD.
• Date Cleared: 1998-06-11 ( 603 days)
• Product Code: DXN
• Regulation Number: 870.1130
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

To measure systolic and diastolic blood pressure and heart rate of the wrist using the oscillometric method. Limited to patient over 18 years and wrist circumference between of 5.3 to 7.7 inches.

Device Description

Not Found

AI/ML Overview

This looks like a 510(k) clearance letter from the FDA for a blood pressure monitor, not a study evaluating an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and AI-specific metrics is not present in the provided document.

To answer your request, I would need a document describing a study conducted to prove the performance of an AI/ML device against specific acceptance criteria.

Regulation Number and Section

§ 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).