Skip to content

Digitrapper Delta Model 9043G0201 and Polygram '98 Ph Extension Model 9043S0111

by Medtronic Functional Diagnostics A/S

510(k) K981733

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK981733 Date4 Feb 1999ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0924-04 FDA Unclassified (pre-2012) initiated 28 Apr 2004

    Inadequate wire insulation inside the plugs of the power cords of the devices may cause the power cords to short.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FFX
Device Class
Class II
Regulation
21 CFR Part 876.1725
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Digitrapper Delta, Model 9043G0201 and Polygram '98 Ph Extension Model 9043S0111 is a gastrointestinal motility (electrical) system used for recording physiological data during normal daily activity. The system includes a Digitrapper Delta recording device and Polygram '98 pH Extension software for analysis on a general-purpose PC. Data is transferred via IrDA 1.1 to the PC for processing.

The device is supplied as a system and is intended for use in clinical settings. It is classified as a Class II device under FDA 510(k) clearance (K981733) and is regulated under regulation number 876.1725. The manufacturer, Medtronic Functional Diagnostics A/S, is based in Skovlunde, Denmark.

Other devices from Medtronic Functional Diagnostics A/S

See all devices from Medtronic Functional Diagnostics A/S →

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Digitrapper Delta used for?

    The Digitrapper Delta is used for recording physiological data during normal daily activity, specifically for gastrointestinal motility.

  • How is the device supplied?

    The device is supplied as a system, including a Digitrapper Delta recording device and Polygram '98 pH Extension software.

  • Is the Digitrapper Delta a single-use or reusable device?

    The description does not specify whether the Digitrapper Delta is single-use or reusable, but it is intended for use in clinical settings.

  • What type of data transfer does the Digitrapper Delta use?

    The Digitrapper Delta transfers data via IrDA 1.1 to a general-purpose PC for processing.