POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111

• K Number: K000386
• Device Name: POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111
• Manufacturer: MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
• Date Cleared: 2000-05-05 ( 88 days)
• Product Code: FFX
• Regulation Number: 876.1725
• Type: Traditional
• Panel: GU
• Reference & Predicate Devices: N/A

Intended Use

Get notified when PDF is available

Device Description

Get notified when PDF is available

AI/ML Overview

Get notified when PDF is available

Regulation Number and Section

§ 876.1725 Gastrointestinal motility monitoring system.

(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).