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FDA 510(k)

AUREX-3

K-Number: K981704 · 1998-08-05

ApplicantAdm Tronics Unltd, Inc.
Decision Date1998-08-05
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUREX-3 is the device name listed in this FDA 510(k) record. The listed applicant is Adm Tronics Unltd, Inc.. It received FDA 510(k) clearance on 1998-08-05 under 510(k) number K981704. The device is classified under product code KLW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUREX-3?

AUREX-3 is a medical device that received FDA 510(k) clearance on 1998-08-05. The listed applicant is Adm Tronics Unltd, Inc.. The 510(k) number is K981704.

When did AUREX-3 receive FDA 510(k) clearance?

AUREX-3 received FDA 510(k) clearance on 1998-08-05, under 510(k) number K981704.

Who is the listed applicant for AUREX-3?

The FDA 510(k) record lists Adm Tronics Unltd, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUREX-3?

The FDA product code for AUREX-3 is KLW.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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