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SLEEPSCAN Airflow Pressure Transducer

by Bio-Logic Systems Corp.

510(k) K971501

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 NumberK971501 Date14 Oct 1997ClearedStatusActive

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  • Withdrawn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
MNR
Device Class
Class II
Regulation
21 CFR Part 868.2375
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 SLEEPSCAN Airflow Pressure Transducer is a device used in sleep disorder studies to detect respiratory airflow for recording onto a physiological recorder. It is designed to measure airflow and transmit data for analysis in sleep studies.

The device is battery-powered and uses a single-use, disposable nasal cannula that attaches to the patient and connects to the transducer. The cannula cannot be cleaned for reuse. The device is supplied as part of a system and is intended for use in clinical settings.

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