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FDA 510(k)

MODIFICATION TO ACCULEAF

K-Number: K040553 · 2004-04-01

ApplicantDirex Systems Corp.
Decision Date2004-04-01
Product CodeIXI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ACCULEAF 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 2004-04-01 under 510(k) number K040553. The device is classified under product code IXI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO ACCULEAF?

MODIFICATION TO ACCULEAF is a medical device that received FDA 510(k) clearance on 2004-04-01. The listed applicant is Direx Systems Corp.. The 510(k) number is K040553.

When did MODIFICATION TO ACCULEAF receive FDA 510(k) clearance?

MODIFICATION TO ACCULEAF received FDA 510(k) clearance on 2004-04-01, under 510(k) number K040553.

Who is the listed applicant for MODIFICATION TO ACCULEAF?

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 MODIFICATION TO ACCULEAF?

The FDA product code for MODIFICATION TO ACCULEAF is IXI.

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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.

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Related Devices (Code: IXI)

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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