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FDA 510(k)

EVA (Enhanced Visual Assessment) System

K-Number: K161871 · 2016-12-19

ApplicantMobileodt , Ltd.
Decision Date2016-12-19
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EVA (Enhanced Visual Assessment) System is the device name listed in this FDA 510(k) record. The listed applicant is Mobileodt , Ltd.. It received FDA 510(k) clearance on 2016-12-19 under 510(k) number K161871. The device is classified under product code HEX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVA (Enhanced Visual Assessment) System?

EVA (Enhanced Visual Assessment) System is a medical device that received FDA 510(k) clearance on 2016-12-19. The listed applicant is Mobileodt , Ltd.. The 510(k) number is K161871.

When did EVA (Enhanced Visual Assessment) System receive FDA 510(k) clearance?

EVA (Enhanced Visual Assessment) System received FDA 510(k) clearance on 2016-12-19, under 510(k) number K161871.

Who is the listed applicant for EVA (Enhanced Visual Assessment) System?

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

What is the FDA product code for EVA (Enhanced Visual Assessment) System?

The FDA product code for EVA (Enhanced Visual Assessment) System is HEX.

Related Devices (Code: HEX)

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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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.

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