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FDA 510(k)

EDLEN IMAGING - GEMINI DUSB

K-Number: K103290 · 2011-09-19

ApplicantEdlen Imaging, LLC
Decision Date2011-09-19
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EDLEN IMAGING - GEMINI DUSB is the device name listed in this FDA 510(k) record. The listed applicant is Edlen Imaging, LLC. It received FDA 510(k) clearance on 2011-09-19 under 510(k) number K103290. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDLEN IMAGING - GEMINI DUSB?

EDLEN IMAGING - GEMINI DUSB is a medical device that received FDA 510(k) clearance on 2011-09-19. The listed applicant is Edlen Imaging, LLC. The 510(k) number is K103290.

When did EDLEN IMAGING - GEMINI DUSB receive FDA 510(k) clearance?

EDLEN IMAGING - GEMINI DUSB received FDA 510(k) clearance on 2011-09-19, under 510(k) number K103290.

Who is the listed applicant for EDLEN IMAGING - GEMINI DUSB?

The FDA 510(k) record lists Edlen Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EDLEN IMAGING - GEMINI DUSB?

The FDA product code for EDLEN IMAGING - GEMINI DUSB is MUH.

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Other records listing Edlen Imaging, LLC 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.

K151137X-VIEW, IMAGEN

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Official Source

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