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Tuba TM (Transit-Time Ultrasonic Breath Analyzer)

by Ghg Medizin-Elektronik AG

510(k) K900331

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 NumberK900331 Date4 Sep 1990ClearedStatusActive

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  • Withdrawn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
BZG
Device Class
Class II
Regulation
21 CFR Part 868.1840
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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 device is a spirometer, diagnostic, classified under regulation number 868.1840 and product code BZG. It is a transit-time ultrasonic breath analyzer (TUBA) used for measuring tidal flow.

It was cleared via the FDA 510(k) pathway under number K900331, with a substantially equivalent decision dated September 4, 1990. The device is intended for use in anesthesiology and requires a warm-up period of at least 20 minutes before use.

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 TUBA TM device used for?

    The TUBA TM is a spirometer, diagnostic, classified as a transit-time ultrasonic breath analyzer used for measuring tidal flow, specifically intended for use in anesthesiology.

  • How is the TUBA TM supplied and prepared for use?

    The TUBA TM requires a warm-up period of at least 20 minutes before use, as specified in its labeling, to ensure accurate tidal flow measurements during anesthesiology procedures.

  • What regulatory pathway was used for the TUBA TM clearance?

    The TUBA TM was cleared via the FDA 510(k) pathway under submission number K900331, receiving a substantially equivalent decision on September 4, 1990.