Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)

K-Number: K240706 · 2024-12-09

ApplicantGanshorn Medizin Electronic GmbH
Decision Date2024-12-09
Product CodeJEH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) is the device name listed in this FDA 510(k) record. The listed applicant is Ganshorn Medizin Electronic GmbH. It received FDA 510(k) clearance on 2024-12-09 under 510(k) number K240706. The device is classified under product code JEH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)?

PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) is a medical device that received FDA 510(k) clearance on 2024-12-09. The listed applicant is Ganshorn Medizin Electronic GmbH. The 510(k) number is K240706.

When did PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) receive FDA 510(k) clearance?

PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) received FDA 510(k) clearance on 2024-12-09, under 510(k) number K240706.

Who is the listed applicant for PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)?

The FDA 510(k) record lists Ganshorn Medizin Electronic GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)?

The FDA product code for PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) is JEH.

Other records listing Ganshorn Medizin Electronic GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160116SpiroScout

Related Devices (Code: JEH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223818Model 9160 VitaloQUBVitalograph Ireland, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑