Skip to content

AbStats Gateway

by Gi Logic, Inc.

510(k) K150782

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK150782 Date14 Dec 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
DQD
Device Class
Class II
Regulation
21 CFR Part 870.1875
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 AbStats Gateway is an electronic stethoscope device that functions as a compact system with integrated sensor interfaces and an embedded computing system. It is designed to be used in conjunction with external sensors placed on the abdomen to identify and process acoustic signals related to digestive states.

This device has received FDA 510(k) clearance under the product code DQD. It is classified as a Class 2 medical device and is regulated under the cardiovascular specialty.

Questions

AI-generated answers, 21 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 primary function of the AbStats Gateway?

    The AbStats Gateway is an electronic stethoscope device designed to work with external sensors placed on the abdomen. Its purpose is to identify and process acoustic signals related to digestive states using an integrated sensor interface and embedded computing system.

  • How is the AbStats Gateway regulated?

    The AbStats Gateway is classified as a Class 2 medical device. It has received FDA 510(k) clearance under product code DQD and is regulated under the cardiovascular specialty.

  • What is the regulatory clearance status of this device?

    The device has received FDA 510(k) clearance, which indicates that it has been found substantially equivalent to a predicate device through a traditional submission process.