510(k) K222794

FlowStar Touch Digital Mixer Flowmeter by Baldus Sedation GmbH & Co. KG — Product Code BZR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2023
Date Received
September 16, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixer, Breathing Gases, Anesthesia Inhalation
Device Class
Class II
Regulation Number
868.5330
Review Panel
AN
Submission Type