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Single Breath Lung Diffus Test Device Spirometery

by Gomi Medical Instruments

510(k) K874902

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK874902 Date7 Jun 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
BZM
Device Class
Class II
Regulation
21 CFR Part 868.1900
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Calculator, Pulmonary Function Interpretor (Diagnostic) as defined in the nomenclature authority. It is designed to perform single breath lung diffusion testing using spirometry methodology.

It is supplied by Gomi Medical Instruments and has received FDA 510(k) clearance under K874902. The device is classified as Class II, with product code BZM, and is intended for use in pulmonary function assessment within the anesthesiology specialty.

Questions

AI-generated answers, 27 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 Single Breath Lung Diffusion Test Device Spirometry used for?

    It is designed to perform single breath lung diffusion testing using spirometry methodology as a pulmonary function interpretor calculator, intended for use in pulmonary function assessment within the anesthesiology specialty.

  • How is the Single Breath Lung Diffusion Test Device Spirometry supplied and is it reusable?

    The device is supplied by Gomi Medical Instruments as a pulmonary function interpretor calculator; however, the provided data does not specify whether it is single-use or reusable, so reuse status cannot be determined from the information given.

  • What regulatory clearance does the Single Breath Lung Diffusion Test Device Spirometry have?

    The device has received FDA 510(k) clearance under submission K874902, is classified as Class II, and has product code BZM, indicating it was found substantially equivalent to a legally marketed predicate device.