VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES

• K Number: K082630
• Device Name: VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES
• Manufacturer: ZEFON INTL.
• Date Cleared: 2008-12-19 ( 100 days)
• Product Code: DXQ
• Regulation Number: 870.1120
• Type: Abbreviated
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

Zefon NIPB blood pressure cuffs, tubing & adapters are reusable accessories used in conjunction with non-invasive automatic blood pressure monitors or non-invasive manual blood pressure measurement systems.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification decision letter from the FDA to Zefon International regarding their VitalCheck Blood Pressure Cuff, NIBP Tubing, and Adapters.

This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval document stating that the FDA has reviewed the device and determined it is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study from the provided text.

Regulation Number and Section

§ 870.1120 Blood pressure cuff.

(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).