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FDA 510(k)

ELEVANCE

K-Number: K120239 · 2012-08-24

ApplicantMidmark
Decision Date2012-08-24
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ELEVANCE is the device name listed in this FDA 510(k) record. The listed applicant is Midmark. It received FDA 510(k) clearance on 2012-08-24 under 510(k) number K120239. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELEVANCE?

ELEVANCE is a medical device that received FDA 510(k) clearance on 2012-08-24. The listed applicant is Midmark. The 510(k) number is K120239.

When did ELEVANCE receive FDA 510(k) clearance?

ELEVANCE received FDA 510(k) clearance on 2012-08-24, under 510(k) number K120239.

Who is the listed applicant for ELEVANCE?

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

What is the FDA product code for ELEVANCE?

The FDA product code for ELEVANCE is EIA.

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Other records listing Midmark 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: EIA)

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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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