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FDA 510(k)

FlowStar Analog Mixer Flowmeter

K-Number: K230987 · 2023-09-14

ApplicantBaldus Sedation GmbH & Co. KG
Decision Date2023-09-14
Product CodeBZR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FlowStar Analog Mixer Flowmeter is the device name listed in this FDA 510(k) record. The listed applicant is Baldus Sedation GmbH & Co. KG. It received FDA 510(k) clearance on 2023-09-14 under 510(k) 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. The listed applicant is Baldus Sedation GmbH & Co. KG. The 510(k) number is K230987.

When did FlowStar Analog Mixer Flowmeter receive FDA 510(k) clearance?

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

Who is the listed applicant for FlowStar Analog Mixer Flowmeter?

The FDA 510(k) record lists Baldus Sedation GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Baldus Sedation GmbH & Co. KG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222794FlowStar Touch Digital Mixer Flowmeter

Related Devices (Code: BZR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243917F&P Optiflow Air/Oxygen Flow SourceFisher & Paykel Healthcare, Ltd.K241465Midas Flowmeter; eAVSParker Hannifin CorporationK231895Maxtec MaxBlend2+pMaxtec, LLCK222794FlowStar Touch Digital Mixer FlowmeterBaldus Sedation GmbH & Co. KGK221494Quality Mix Blender, OxymixerDehas Medical Systems GmbHK202480Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50Parker Hannifin

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.

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