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FDA 510(k)

OMNIVision system

K-Number: K203751 · 2021-04-12

ApplicantCorin USA
Decision Date2021-04-12
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OMNIVision system is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 2021-04-12 under 510(k) number K203751. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNIVision system?

OMNIVision system is a medical device that received FDA 510(k) clearance on 2021-04-12. The listed applicant is Corin USA. The 510(k) number is K203751.

When did OMNIVision system receive FDA 510(k) clearance?

OMNIVision system received FDA 510(k) clearance on 2021-04-12, under 510(k) number K203751.

Who is the listed applicant for OMNIVision system?

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

What is the FDA product code for OMNIVision system?

The FDA product code for OMNIVision system is OLO.

Other records listing Corin USA as applicant

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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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