TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX

• K Number: K080189
• Device Name: TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX
• Manufacturer: TRIMLINE MEDICAL PRODUCTS CORP.
• Date Cleared: 2008-08-15 ( 203 days)
• Product Code: DXQ
• Regulation Number: 870.1120
• Type: Abbreviated
• Panel: CV
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The TRIMLINE Tempa-Kuff Blood Pressure Cuff:

• is an accessory used in conjunction with non-invasive blood pressure measuring systems
• is non-sterile and may be used on a limited basis :
• . may be used with neonatal, pediatric and adult patients

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for the TRIMLINE™ Tempa-Kuff® Blood Pressure Cuff. It confirms that the device is substantially equivalent to legally marketed predicate devices.

The provided text does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. Therefore, I cannot fulfill your request based on the given input.

The document is purely a regulatory approval letter and does not describe the technical details of the device's validation.

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).