FDA 510(k)

DART-12

K-Number: K052705 · 2006-02-21

Decision Date2006-02-21

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DART-12 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 2006-02-21 under 510(k) number K052705. 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 DART-12?

DART-12 is a medical device that received FDA 510(k) clearance on 2006-02-21. The listed applicant is Direx Systems Corp.. The 510(k) number is K052705.

When did DART-12 receive FDA 510(k) clearance?

DART-12 received FDA 510(k) clearance on 2006-02-21, under 510(k) number K052705.

Who is the listed applicant for DART-12?

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 DART-12?

The FDA product code for DART-12 is IYE.

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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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.