FlowStar Analog Mixer Flowmeter— 510(k) K230987

Name: FDA 510(k) clearance K230987
Creator: U.S. Food and Drug Administration
Published: 2023-09-14

Substantially Equivalent

Baldus Sedation GmbH & Co. KG

FDA 510(k) clearance K230987 for FlowStar Analog Mixer Flowmeter, Substantially Equivalent on 2023-09-14. 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: 2023-04-06
Decision date: 2023-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bendorf, DE

Download summary PDF View on FDA.gov ↗

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