Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Midmark Extraoral Imaging System (EOIS)

K-Number: K201667 · 2020-08-06

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

Device Summary

Midmark Extraoral Imaging System (EOIS) is a medical device manufactured by Midmark Corporation. It received FDA 510(k) clearance on 2020-08-06 under approval 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. It is manufactured by Midmark Corporation. The 510(k) number is K201667.

When was Midmark Extraoral Imaging System (EOIS) approved by the FDA?

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

What company makes Midmark Extraoral Imaging System (EOIS)?

Midmark Extraoral Imaging System (EOIS) is manufactured by Midmark Corporation.

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

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

Related Clinical Trials

Related PubMed Literature

Other Devices by Midmark Corporation

Related Devices (Code: OAS)

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.