Quality Mix Blender, Oxymixer— 510(k) K221494

Name: FDA 510(k) clearance K221494
Creator: U.S. Food and Drug Administration
Published: 2023-01-23

Substantially Equivalent

Dehas Medical Systems GmbH

FDA 510(k) clearance K221494 for Quality Mix Blender, Oxymixer, Substantially Equivalent on 2023-01-23. Applicant: Dehas Medical Systems GmbH. Device class: 2.

Clearance details

Applicant: Dehas Medical Systems GmbH
Product code: Code BZR
Device class: Class 2
Regulation: 21 CFR 868.5330
Advisory panel: Anesthesiology
Date received: 2022-05-23
Decision date: 2023-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Luebeck, DE

Download summary PDF View on FDA.gov ↗

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