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Alarm Used W/Monitoring Spirometer

by Empire Plastics Manufacturer

510(k) K792573

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 NumberK792573 Date31 Dec 1979ClearedStatusActive

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  • Withdrawn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
BZK
Device Class
Class II
Regulation
21 CFR Part 868.1850
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a spirometer with monitoring capability that includes an alarm function. It is classified as a spirometer, monitoring (with or without alarm) under FDA product code BZK.

It was cleared through the FDA 510(k) process under submission K792573 by Empire Plastics Manufacturer, with a decision of substantially equivalent on December 31, 1979. The device is intended for use in anesthesiology settings and is regulated as a Class II medical device.

Other devices from Empire Plastics Manufacturer

Questions

AI-generated answers, 1 Oct 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 ALARM USED W/MONITORING SPIROMETER used for?

    This device is a spirometer with monitoring capability that includes an alarm function, intended for use in anesthesiology settings to monitor respiratory parameters and alert clinicians to changes.

  • How was the ALARM USED W/MONITORING SPIROMETER cleared for market?

    The device was cleared through the FDA 510(k) process under submission K792573 by Empire Plastics Manufacturer, with a determination of substantially equivalent on December 31, 1979.

  • What regulatory classification does the ALARM USED W/MONITORING SPIROMETER have?

    The device is classified as a Class II medical device under FDA product code BZK, which covers spirometers with monitoring capability, with or without an alarm function.