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FDA 510(k)

IMPERIUM

K-Number: K022114 · 2002-09-17

ApplicantElmstech, Inc.
Decision Date2002-09-17
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMPERIUM is the device name listed in this FDA 510(k) record. The listed applicant is Elmstech, Inc.. It received FDA 510(k) clearance on 2002-09-17 under 510(k) number K022114. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPERIUM?

IMPERIUM is a medical device that received FDA 510(k) clearance on 2002-09-17. The listed applicant is Elmstech, Inc.. The 510(k) number is K022114.

When did IMPERIUM receive FDA 510(k) clearance?

IMPERIUM received FDA 510(k) clearance on 2002-09-17, under 510(k) number K022114.

Who is the listed applicant for IMPERIUM?

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

What is the FDA product code for IMPERIUM?

The FDA product code for IMPERIUM is OWB.

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Related Devices (Code: OWB)

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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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