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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation
510(k) Number K222794
Device Name FlowStar Touch Digital Mixer Flowmeter
Applicant
Baldus Sedation GmbH & Co. KG
In der Langfuhr 32
Bendorf,  DE 56170
Applicant Contact Lisa Baldus
Correspondent
Kamm & Assosciates
8870 Ravello Ct
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number868.5330
Classification Product Code
BZR  
Date Received09/16/2022
Decision Date 07/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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