MS-753 MARS INFLATE-READ BLOOD PRESSURE MONITOR

• K Number: K050040
• Device Name: MS-753 MARS INFLATE-READ BLOOD PRESSURE MONITOR
• Manufacturer: MARS MEDICAL PRODUCTS
• Date Cleared: 2005-03-30 ( 82 days)
• Product Code: DXN
• Regulation Number: 870.1130
• Type: Traditional
• Panel: Cardiovascular
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

1. The device is designed to provide signals from which systolic and diastolic pressures can be derived through the use of the Oscillometric method. \ The device also measure pulse rate.

• 2. The device is for adult use only.
• The device is for use at home or while traveling. 3.

Device Description

MS-753 Mars Inflate-Read Blood Pressure Monitor

AI/ML Overview

This document is a 510(k) clearance letter for the "MS-930 Mars Inflate-Read Blood Pressure Monitor". It does not contain the acceptance criteria and study details as requested. A 510(k) clearance letter typically states that a device is substantially equivalent to a predicate device, allowing it to be marketed, but it does not detail the specific performance studies and acceptance criteria from the submission itself.

Therefore, I cannot extract the requested information from the provided text. The document confirms the clearance of the device and its indications for use, but not the technical study details.

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).