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PFM Professional 7000 Spirometer

by Advanced Medical Systems, Inc.

510(k) K932278

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 NumberK932278 Date17 Dec 1993ClearedStatusActive

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  • Withdrawn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
BTY
Device Class
Class II
Regulation
21 CFR Part 868.1890
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 PFM Professional 7000 Spirometer is a pulmonary function device classified as a Calculator, Predicted Values, Pulmonary Function under FDA regulation. It is a Class II medical device with product code BTY and regulation number 868.1890, cleared via the traditional 510(k) pathway as substantially equivalent to a predicate device.

The device was cleared by the FDA on December 17, 1993, under K932278, and is intended for use in the field of anesthesiology. It is manufactured by Advanced Medical Systems, Inc., and its authorization is based on a traditional 510(k) submission received on May 12, 1993.

Other devices from Advanced Medical Systems, Inc.

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Questions

AI-generated answers, 22 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 PFM Professional 7000 Spirometer used for?

    The PFM Professional 7000 Spirometer is intended for use in the field of anesthesiology as a pulmonary function device that calculates predicted values, based on its FDA classification as a Calculator, Predicted Values, Pulmonary Function under product code BTY.

  • How was the PFM Professional 7000 Spirometer cleared for market?

    The device was cleared via the traditional 510(k) pathway under K932278 on December 17, 1993, as substantially equivalent to a predicate device, following a submission received on May 12, 1993, by Advanced Medical Systems, Inc.

  • What regulatory classification and product code apply to the PFM Professional 7000 Spirometer?

    The PFM Professional 7000 Spirometer is classified as a Class II medical device with product code BTY and regulation number 868.1890, falling under the FDA category of Calculator, Predicted Values, Pulmonary Function.