Cleared Traditional

FlowStar Touch Digital Mixer Flowmeter

K222794 · Baldus Sedation GmbH & Co. KG · Anesthesiology

Jul 2023

Decision

315d

Days

Class 2

Risk

About This 510(k) Submission

K222794 is an FDA 510(k) clearance for the FlowStar Touch Digital Mixer Flowmeter, a Mixer, Breathing Gases, Anesthesia Inhalation (Class II — Special Controls, product code BZR), submitted by Baldus Sedation GmbH & Co. KG (Bendorf, DE). The FDA issued a Cleared decision on July 28, 2023, 315 days after receiving the submission on September 16, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5330.

Submission Details

510(k) Number	K222794 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 2022
Decision Date	July 28, 2023
Days to Decision	315 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF