ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46

• K Number: K993432
• Device Name: ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46
• Manufacturer: ROSSMAX INTERNATIONAL LTD.
• Date Cleared: 1999-12-20 ( 69 days)
• Product Code: DXN
• Regulation Number: 870.1130
• Type: Special
• Panel: CV
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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

Device Description

Rossmax Automatic Wristwatch Blood Pressure Monitor, model Z46

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA letter granting substantial equivalence for a blood pressure monitor, focusing on regulatory aspects rather than detailed study results. Therefore, I cannot generate the requested table and information.

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).