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FDA 510(k)

MIGUE

K-Number: K052212 · 2006-03-10

ApplicantDirex Systems Corp.
Decision Date2006-03-10
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MIGUE is the device name listed in this FDA 510(k) record. The listed applicant is Direx Systems Corp.. It received FDA 510(k) clearance on 2006-03-10 under 510(k) number K052212. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIGUE?

MIGUE is a medical device that received FDA 510(k) clearance on 2006-03-10. The listed applicant is Direx Systems Corp.. The 510(k) number is K052212.

When did MIGUE receive FDA 510(k) clearance?

MIGUE received FDA 510(k) clearance on 2006-03-10, under 510(k) number K052212.

Who is the listed applicant for MIGUE?

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

What is the FDA product code for MIGUE?

The FDA product code for MIGUE is IYE.

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Other records listing Direx Systems Corp. 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.

K111947DUET MAGNAK102765PRONEXK072529TRACKPORTK071701TRACKLEAF-10K063482CROSSPLAN / ACCUSOFT-XL V.4.04K062147INTEGRA SL

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Related Devices (Code: IYE)

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.

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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.

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