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FDA 510(k)

MAGIS1;MAGIS2

K-Number: K061713 · 2006-07-21

ApplicantDirex Systems Corp.
Decision Date2006-07-21
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAGIS1;MAGIS2 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 2006-07-21 under 510(k) number K061713. 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 MAGIS1;MAGIS2?

MAGIS1;MAGIS2 is a medical device that received FDA 510(k) clearance on 2006-07-21. The listed applicant is Direx Systems Corp.. The 510(k) number is K061713.

When did MAGIS1;MAGIS2 receive FDA 510(k) clearance?

MAGIS1;MAGIS2 received FDA 510(k) clearance on 2006-07-21, under 510(k) number K061713.

Who is the listed applicant for MAGIS1;MAGIS2?

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 MAGIS1;MAGIS2?

The FDA product code for MAGIS1;MAGIS2 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)

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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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