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FDA 510(k)

Midmark Extraoral Imaging System (EOIS)

K-Number: K201667 · 2020-08-06

ApplicantMidmark Corporation
Decision Date2020-08-06
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Midmark Extraoral Imaging System (EOIS) is the device name listed in this FDA 510(k) record. The listed applicant is Midmark Corporation. It received FDA 510(k) clearance on 2020-08-06 under 510(k) number K201667. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Midmark Extraoral Imaging System (EOIS)?

Midmark Extraoral Imaging System (EOIS) is a medical device that received FDA 510(k) clearance on 2020-08-06. The listed applicant is Midmark Corporation. The 510(k) number is K201667.

When did Midmark Extraoral Imaging System (EOIS) receive FDA 510(k) clearance?

Midmark Extraoral Imaging System (EOIS) received FDA 510(k) clearance on 2020-08-06, under 510(k) number K201667.

Who is the listed applicant for Midmark Extraoral Imaging System (EOIS)?

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

What is the FDA product code for Midmark Extraoral Imaging System (EOIS)?

The FDA product code for Midmark Extraoral Imaging System (EOIS) is OAS.

Other records listing Midmark Corporation as applicant

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Related Devices (Code: OAS)

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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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