FDA 510(k)

FlowStar Analog Mixer Flowmeter

K-Number: K230987 · 2023-09-14

Decision Date2023-09-14

Product CodeBZR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

FlowStar Analog Mixer Flowmeter is a medical device manufactured by Baldus Sedation GmbH & Co. KG. It received FDA 510(k) clearance on 2023-09-14 under approval number K230987. 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 Analog Mixer Flowmeter?

FlowStar Analog Mixer Flowmeter is a medical device that received FDA 510(k) clearance on 2023-09-14. It is manufactured by Baldus Sedation GmbH & Co. KG. The 510(k) number is K230987.

When was FlowStar Analog Mixer Flowmeter approved by the FDA?

FlowStar Analog Mixer Flowmeter received FDA 510(k) clearance on 2023-09-14, under approval number K230987.

What company makes FlowStar Analog Mixer Flowmeter?

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

What is the FDA product code for FlowStar Analog Mixer Flowmeter?

The FDA product code for FlowStar Analog Mixer Flowmeter is BZR.

Other Devices by Baldus Sedation GmbH & Co. KG

K222794FlowStar Touch Digital 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 K222794FlowStar Touch Digital Mixer FlowmeterBaldus Sedation GmbH & Co. KG K221494Quality Mix Blender, OxymixerDehas Medical Systems GmbH

Official Source

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