Cleared Traditional

ALADDIN MONITORING OXYGEN/AIR MIXER

K960359 · Hamilton Medical, Inc. · Anesthesiology
Apr 1996
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K960359 is an FDA 510(k) clearance for the ALADDIN MONITORING OXYGEN/AIR MIXER, a Mixer, Breathing Gases, Anesthesia Inhalation (Class II — Special Controls, product code BZR), submitted by Hamilton Medical, Inc. (Reno, US). The FDA issued a Cleared decision on April 24, 1996, 90 days after receiving the submission on January 25, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5330.

Submission Details

510(k) Number K960359 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 1996
Decision Date April 24, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BZR — Mixer, Breathing Gases, Anesthesia Inhalation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5330

Similar Devices — BZR Mixer, Breathing Gases, Anesthesia Inhalation

All 54
F&P Optiflow Air/Oxygen Flow Source
K243917 · Fisher &Paykel Healthcare , Ltd. · Jul 2025
Midas Flowmeter; eAVS
K241465 · Parker Hannifin Corporation · Sep 2024
Maxtec MaxBlend2+p
K231895 · Maxtec, LLC · Dec 2023
FlowStar Analog Mixer Flowmeter
K230987 · Baldus Sedation GmbH & Co. KG · Sep 2023
FlowStar Touch Digital Mixer Flowmeter
K222794 · Baldus Sedation GmbH & Co. KG · Jul 2023
Quality Mix Blender, Oxymixer
K221494 · Dehas Medical Systems GmbH · Jan 2023