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Pre-Set 50/50 Nitrous Oxide/Oxygen Mixer

by Fraser Sweatman, Inc. 510(k)

Active United States

510(k) K760766

Overview

The Pre-Set 50/50 Nitrous Oxide/Oxygen Mixer is a breathing gas mixer for anesthesia inhalation. It is designed to provide a 50/50 mixture of nitrous oxide and oxygen to patients.

This device is supplied by Fraser Sweatman, Inc. and is authorized under FDA 510K clearance K760766. It is a Class II device with product code BZR and is intended for use in anesthesiology settings.

AI-generated from registry data, 28 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK760766 Date8 Oct 1976ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
BZR
Device Class
Class II
Regulation
21 CFR Part 868.5330
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from Fraser Sweatman, Inc.

Questions

  • What is the Pre-Set 50/50 Nitrous Oxide/Oxygen Mixer used for?

    This device is a breathing gas mixer designed for anesthesia inhalation, providing a precise 50/50 mixture of nitrous oxide and oxygen to patients in anesthesiology settings.

  • How is the Pre-Set 50/50 Nitrous Oxide/Oxygen Mixer supplied?

    The device is supplied by Fraser Sweatman, Inc. and is authorized under FDA 510K clearance K760766. It is a Class II device with product code BZR.

  • What is the regulatory status of the Pre-Set 50/50 Nitrous Oxide/Oxygen Mixer?

    The device has FDA 510K clearance K760766 and is classified as a Class II device with product code BZR. It is intended for use in anesthesiology settings and has been determined to be substantially equivalent.

  • Is the Pre-Set 50/50 Nitrous Oxide/Oxygen Mixer reusable or single-use?

    The device data does not specify whether the Pre-Set 50/50 Nitrous Oxide/Oxygen Mixer is designed for single-use or multiple uses. This information would need to be confirmed with the manufacturer or product documentation.