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FDA 510(k)

MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED

K-Number: K092391 · 2010-04-01

ApplicantConcord Medical Products
Decision Date2010-04-01
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED is the device name listed in this FDA 510(k) record. The listed applicant is Concord Medical Products. It received FDA 510(k) clearance on 2010-04-01 under 510(k) number K092391. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED?

MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED is a medical device that received FDA 510(k) clearance on 2010-04-01. The listed applicant is Concord Medical Products. The 510(k) number is K092391.

When did MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED receive FDA 510(k) clearance?

MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED received FDA 510(k) clearance on 2010-04-01, under 510(k) number K092391.

Who is the listed applicant for MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED?

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

What is the FDA product code for MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED?

The FDA product code for MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED is MKJ. This falls under the Dental category.

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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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