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PM-80 Pulmotester

by Future Impex Corp. 510(k)

Active United States

510(k) K843984

Overview

The PM-80 Pulmotester is a diagnostic spirometer, a device used for pulmonary function testing. It measures the volume and flow of gas moving in and out of a patient’s lungs to assess lung function, typically used in clinical settings such as pulmonary function labs or anesthesiology departments.

The PM-80 Pulmotester is supplied as a reusable device and is classified under FDA regulation number 868.1840. It was granted FDA 510(k) clearance under the traditional review pathway in 1984, with a decision code of SESE (Substantially Equivalent). No specific sterility or MRI safety information is provided in the available data.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK843984 Date24 Oct 1984ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
BZG
Device Class
Class II
Regulation
21 CFR Part 868.1840
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the PM-80 Pulmotester used for?

    The PM-80 Pulmotester is a diagnostic spirometer used to measure the volume and flow of gas moving in and out of a patient’s lungs to assess lung function, typically in clinical settings such as pulmonary function labs or anesthesiology departments.

  • Is the PM-80 Pulmotester a reusable or single-use device?

    The PM-80 Pulmotester is supplied as a reusable device, meaning it is designed for multiple uses after appropriate cleaning and maintenance between patients.

  • How was the PM-80 Pulmotester cleared for marketing in the United States?

    The PM-80 Pulmotester received FDA 510(k) clearance through the traditional review pathway in 1984, with a decision code of SESE, indicating it was found substantially equivalent to a legally marketed predicate device.

  • What regulatory classification and product code apply to the PM-80 Pulmotester?

    The PM-80 Pulmotester is classified under FDA regulation number 868.1840 and has the product code BZG, which corresponds to a diagnostic spirometer.

  • Does the PM-80 Pulmotester come sterile or require sterilization before use?

    No specific sterility information is provided in the available data for the PM-80 Pulmotester; therefore, it cannot be assumed to be supplied sterile, and users should follow manufacturer-recommended cleaning and disinfection procedures prior to each use.