Cleared Traditional

Midas Flowmeter; eAVS

K241465 · Parker Hannifin Corporation · Anesthesiology
Sep 2024
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K241465 is an FDA 510(k) clearance for the Midas Flowmeter; eAVS, a Mixer, Breathing Gases, Anesthesia Inhalation (Class II — Special Controls, product code BZR), submitted by Parker Hannifin Corporation (Hatfield, US). The FDA issued a Cleared decision on September 19, 2024, 119 days after receiving the submission on May 23, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5330.

Submission Details

510(k) Number K241465 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2024
Decision Date September 19, 2024
Days to Decision 119 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

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

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