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L.A.P. II Spriometry System

by Allied Healthcare Products, Inc.

510(k) K932936

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 NumberK932936 Date10 Feb 1994ClearedStatusActive

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  • Withdrawn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, 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 L.A.P. II Spirometry System is a diagnostic spirometer. It is designed to measure and record the volume and flow of air inhaled and exhaled by a patient to assist in clinical assessment.

This device is classified as an FDA class 2 medical device under regulation number 868.1840. It received FDA 510(k) clearance on February 10, 1994, under the application number K932936.

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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 primary function of the L.A.P. II Spirometry System?

    This device is a diagnostic spirometer intended to measure and record the volume and flow of air inhaled and exhaled by a patient. It is used to assist clinicians in performing patient assessments.

  • What is the regulatory classification of this device?

    The L.A.P. II Spirometry System is classified as an FDA class 2 medical device under regulation number 868.1840. It received FDA 510(k) clearance on February 10, 1994, under application number K932936.

  • Who is the manufacturer of the L.A.P. II Spirometry System?

    The device is manufactured by Allied Healthcare Products, Inc., located in Saint Louis, Missouri.