FlowStar Touch Digital Mixer Flowmeter— 510(k) K222794

Name: FDA 510(k) clearance K222794
Creator: U.S. Food and Drug Administration
Published: 2023-07-28

Substantially Equivalent

Baldus Sedation GmbH & Co. KG

FDA 510(k) clearance K222794 for FlowStar Touch Digital Mixer Flowmeter, Substantially Equivalent on 2023-07-28. Applicant: Baldus Sedation GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Baldus Sedation GmbH & Co. KG
Product code: Code BZR
Device class: Class 2
Regulation: 21 CFR 868.5330
Advisory panel: Anesthesiology
Date received: 2022-09-16
Decision date: 2023-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bendorf, DE

Download summary PDF View on FDA.gov ↗

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