FDA 510(k)

FlowStar Touch Digital Mixer Flowmeter

K-Number: K222794 · 2023-07-28

Decision Date2023-07-28

Product CodeBZR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

FlowStar Touch Digital Mixer Flowmeter is a medical device manufactured by Baldus Sedation GmbH & Co. KG. It received FDA 510(k) clearance on 2023-07-28 under approval number K222794. The device is classified under product code BZR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FlowStar Touch Digital Mixer Flowmeter?

FlowStar Touch Digital Mixer Flowmeter is a medical device that received FDA 510(k) clearance on 2023-07-28. It is manufactured by Baldus Sedation GmbH & Co. KG. The 510(k) number is K222794.

When was FlowStar Touch Digital Mixer Flowmeter approved by the FDA?

FlowStar Touch Digital Mixer Flowmeter received FDA 510(k) clearance on 2023-07-28, under approval number K222794.

What company makes FlowStar Touch Digital Mixer Flowmeter?

FlowStar Touch Digital Mixer Flowmeter is manufactured by Baldus Sedation GmbH & Co. KG.

What is the FDA product code for FlowStar Touch Digital Mixer Flowmeter?

The FDA product code for FlowStar Touch Digital Mixer Flowmeter is BZR.

Other Devices by Baldus Sedation GmbH & Co. KG

K230987FlowStar Analog Mixer Flowmeter

Related Devices (Code: BZR)

K161718MaxBlend 2, MaxBlend LiteMaxtec, LLC K173205Equinox AdvantageO-Two Medical Technologies, Inc. K202480Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50Parker Hannifin K231895Maxtec MaxBlend2+pMaxtec, LLC K230987FlowStar Analog Mixer FlowmeterBaldus Sedation GmbH & Co. KG K221494Quality Mix Blender, OxymixerDehas Medical Systems GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.