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AS165 Respiration Monitor

by Air-Shields, Inc.

510(k) K861743

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 NumberK861743 Date9 May 1986ClearedStatusActive

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  • Withdrawn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
BZQ
Device Class
Class II
Regulation
21 CFR Part 868.2375
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 AS165 Respiration Monitor is a device designed to monitor breathing frequency. It is classified as a Monitor, Breathing Frequency and is intended for use in anesthesiology settings.

The device is supplied by Air-Shields, Inc. and is authorized under FDA 510(k) clearance K861743 with a product code BZQ. It is a Class II device that was cleared as substantially equivalent on May 9, 1986.

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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 AS165 Respiration Monitor used for?

    The AS165 Respiration Monitor is designed to monitor breathing frequency and is intended for use in anesthesiology settings. It helps clinicians track a patient's respiratory rate during medical procedures.

  • How is the AS165 Respiration Monitor supplied?

    The AS165 Respiration Monitor is supplied by Air-Shields, Inc. It is a Class II device that was cleared as substantially equivalent on May 9, 1986, under FDA 510(k) clearance K861743 with product code BZQ.

  • What is the regulatory status of the AS165 Respiration Monitor?

    The AS165 Respiration Monitor is authorized under FDA 510(k) clearance K861743. It is classified as a Class II device and was cleared as substantially equivalent on May 9, 1986, for monitoring breathing frequency in anesthesiology settings.

  • Is the AS165 Respiration Monitor reusable or single-use?

    The device data does not specify whether the AS165 Respiration Monitor is designed for single-use or multiple uses. For information on reusability, please consult the manufacturer's instructions or contact Air-Shields, Inc. directly.