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Snoring Sensor

by Epm Development Systems Corp. 510(k)

Active United States

510(k) K941759

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)ST Traditional NumberK941759 Date10 Nov 1994DecidedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
BZQ
Device Class
Class II
Regulation
21 CFR Part 868.2375
Advisory Committee
Anesthesiology
FDA Decision
ST

Overview

AI-generated summary, 26 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 Snoring Sensor is a ventilatory effort recorder that utilizes PAT technology to record snoring intensity in decibels and body position signals. It can be attached to the patient's chest right under the sternal notch for monitoring purposes.

This device is subject to tracking regulations and is classified as a Class II medical device. It is supplied by Epm Development Systems Corp. and received FDA 510(k) clearance on November 10, 1994, with the product code BZQ.

Questions

AI-generated answers, 26 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 Snoring Sensor used for?

    The Snoring Sensor is a ventilatory effort recorder that utilizes PAT technology to record snoring intensity in decibels and body position signals. It is designed to be attached to the patient's chest under the sternal notch for monitoring purposes.

  • How is the Snoring Sensor supplied?

    The Snoring Sensor is supplied by Epm Development Systems Corp. It is a Class II medical device that is subject to tracking regulations, as indicated by its FDA 510(k) clearance with product code BZQ.

  • What is the regulatory status of the Snoring Sensor?

    The Snoring Sensor received FDA 510(k) clearance on November 10, 1994, with the product code BZQ. It is classified as a Class II medical device and is subject to tracking regulations. The device was reviewed under the Anesthesiology advisory committee.

  • How is the Snoring Sensor attached to the patient?

    The Snoring Sensor is designed to be attached to the patient's chest right under the sternal notch for monitoring purposes. This placement allows it to effectively record snoring intensity and body position signals.