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FDA 510(k)

AURIUM 830

K-Number: K940788 · 1994-03-28

ApplicantArgen Precious Metals, Inc.
Decision Date1994-03-28
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AURIUM 830 is the device name listed in this FDA 510(k) record. The listed applicant is Argen Precious Metals, Inc.. It received FDA 510(k) clearance on 1994-03-28 under 510(k) number K940788. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AURIUM 830?

AURIUM 830 is a medical device that received FDA 510(k) clearance on 1994-03-28. The listed applicant is Argen Precious Metals, Inc.. The 510(k) number is K940788.

When did AURIUM 830 receive FDA 510(k) clearance?

AURIUM 830 received FDA 510(k) clearance on 1994-03-28, under 510(k) number K940788.

Who is the listed applicant for AURIUM 830?

The FDA 510(k) record lists Argen Precious Metals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AURIUM 830?

The FDA product code for AURIUM 830 is EJT.

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Other records listing Argen Precious Metals, Inc. as applicant

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Related Devices (Code: EJT)

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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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