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FDA 510(k)

FlowStar Touch Digital Mixer Flowmeter

K-Number: K222794 · 2023-07-28

ApplicantBaldus Sedation GmbH & Co. KG
Decision Date2023-07-28
Product CodeBZR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FlowStar Touch Digital 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 2023-07-28 under 510(k) 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. The listed applicant is Baldus Sedation GmbH & Co. KG. The 510(k) number is K222794.

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

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

Who is the listed applicant for FlowStar Touch Digital 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 Touch Digital Mixer Flowmeter?

The FDA product code for FlowStar Touch Digital 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.

K230987FlowStar Analog 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, LLCK230987FlowStar Analog 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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