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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
Predetermined Change
Control Plan Authorized		 No
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