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Gas Module 3

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

510(k) K180788

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 NumberK180788 Date24 Oct 2018ClearedStatusActive

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  • Withdrawn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, 21 Sep 2026

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

Gas Module 3 is a spirometer monitoring device intended for the monitoring of airway gases during anesthesia and/or assisted respiration. It is designed for use in the anesthesia department, including the operating room. The device is classified under product code BZK and is regulated under regulation number 868.1850 as a class II device.

The device is supplied by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. and is intended for single or multiple patient use as specified in the manufacturer's instructions. It is designed for use in clinical settings where monitoring of airway gases is required. The device is stored in a dry environment and should be handled according to the manufacturer's guidelines. The device has been reviewed by the Anesthesiology advisory committee and was found to be substantially equivalent to existing devices.

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Questions

AI-generated answers, 21 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 Gas Module 3 used for?

    The Gas Module 3 is a spirometer monitoring device intended for the monitoring of airway gases during anesthesia and/or assisted respiration. It is specifically designed for use in the anesthesia department, including the operating room, where continuous monitoring of respiratory gases is essential for patient safety.

  • How is the Gas Module 3 supplied and handled?

    The device is supplied by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. and is intended for single or multiple patient use as specified in the manufacturer's instructions. It should be stored in a dry environment and handled according to the manufacturer's guidelines to ensure proper function and longevity.

  • Is the Gas Module 3 sterile?

    The device data does not specify whether the Gas Module 3 is supplied sterile. Users should refer to the manufacturer's instructions for details on sterility, cleaning, and disinfection protocols before clinical use.

  • What sizes and models are available?

    The device data provided is specific to the Gas Module 3 model. No additional sizes, variants, or alternative models are listed in the available information. For further details on compatible configurations, consult the manufacturer's documentation.

  • What is the regulatory classification of the Gas Module 3?

    The Gas Module 3 is classified under product code BZK and is regulated under regulation number 868.1850 as a class II device. It has been reviewed by the Anesthesiology advisory committee and was found to be substantially equivalent to existing devices.