PowerCube+ Series (3 models)— 510(k) K240706

Name: FDA 510(k) clearance K240706
Creator: U.S. Food and Drug Administration
Published: 2024-12-09

Substantially Equivalent

Ganshorn Medizin Electronic GmbH

FDA 510(k) clearance K240706 for PowerCube+ Series (3 models), Substantially Equivalent on 2024-12-09. Applicant: Ganshorn Medizin Electronic GmbH. Device class: 2.

Clearance details

Device name as filed: PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)
Applicant: Ganshorn Medizin Electronic GmbH
Product code: Code JEH
Device class: Class 2
Regulation: 21 CFR 868.1760
Advisory panel: Anesthesiology
Date received: 2024-03-14
Decision date: 2024-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niederlauer, DE

Download summary PDF View on FDA.gov ↗

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