Cleared Traditional

FlowStar Analog Mixer Flowmeter

K230987 · Baldus Sedation GmbH & Co. KG · Anesthesiology

Sep 2023

Decision

161d

Days

Class 2

Risk

About This 510(k) Submission

K230987 is an FDA 510(k) clearance for the FlowStar Analog 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 September 14, 2023, 161 days after receiving the submission on April 6, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5330.

Submission Details

510(k) Number	K230987 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 2023
Decision Date	September 14, 2023
Days to Decision	161 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF