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FDA 510(k)

ACCUCHANGER

K-Number: K043409 · 2005-05-05

ApplicantDirex Systems Corp.
Decision Date2005-05-05
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACCUCHANGER 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 2005-05-05 under 510(k) number K043409. 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 ACCUCHANGER?

ACCUCHANGER is a medical device that received FDA 510(k) clearance on 2005-05-05. The listed applicant is Direx Systems Corp.. The 510(k) number is K043409.

When did ACCUCHANGER receive FDA 510(k) clearance?

ACCUCHANGER received FDA 510(k) clearance on 2005-05-05, under 510(k) number K043409.

Who is the listed applicant for ACCUCHANGER?

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 ACCUCHANGER?

The FDA product code for ACCUCHANGER 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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