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FDA 510(k)

DUET MAGNA

K-Number: K111947 · 2012-03-01

ApplicantDirex Systems Corp.
Decision Date2012-03-01
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DUET MAGNA 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 2012-03-01 under 510(k) number K111947. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUET MAGNA?

DUET MAGNA is a medical device that received FDA 510(k) clearance on 2012-03-01. The listed applicant is Direx Systems Corp.. The 510(k) number is K111947.

When did DUET MAGNA receive FDA 510(k) clearance?

DUET MAGNA received FDA 510(k) clearance on 2012-03-01, under 510(k) number K111947.

Who is the listed applicant for DUET MAGNA?

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 DUET MAGNA?

The FDA product code for DUET MAGNA is LNS.

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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.

K102765PRONEXK072529TRACKPORTK071701TRACKLEAF-10K063482CROSSPLAN / ACCUSOFT-XL V.4.04K062147INTEGRA SLK062032ACCUSOFT, ACCUSOFT XL

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Related Devices (Code: LNS)

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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