ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43

• K Number: K993460
• Device Name: ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43
• Manufacturer: ROSSMAX INTERNATIONAL LTD.
• Date Cleared: 2000-01-11 ( 90 days)
• Product Code: DXN
• Regulation Number: 870.1130
• Type: Special
• Panel: CV
• Reference & Predicate Devices: 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 ZA3

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the "Rossmax Automatic Wristwatch Blood Pressure Monitors, Z-series." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the given input.

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).