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FDA 510(k)

GEMINI E

K-Number: K993623 · 2000-06-23

ApplicantAllen Medical Instruments Corp.
Decision Date2000-06-23
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GEMINI E is the device name listed in this FDA 510(k) record. The listed applicant is Allen Medical Instruments Corp.. It received FDA 510(k) clearance on 2000-06-23 under 510(k) number K993623. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEMINI E?

GEMINI E is a medical device that received FDA 510(k) clearance on 2000-06-23. The listed applicant is Allen Medical Instruments Corp.. The 510(k) number is K993623.

When did GEMINI E receive FDA 510(k) clearance?

GEMINI E received FDA 510(k) clearance on 2000-06-23, under 510(k) number K993623.

Who is the listed applicant for GEMINI E?

The FDA 510(k) record lists Allen Medical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEMINI E?

The FDA product code for GEMINI E is DQD.

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Official Source

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

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