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FDA 510(k)

4K UHD Camera System

K-Number: K200216 · 2020-08-21

ApplicantScivita Medical Technology Co., Ltd.
Decision Date2020-08-21
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

4K UHD Camera System is a medical device manufactured by Scivita Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-08-21 under approval number K200216. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4K UHD Camera System?

4K UHD Camera System is a medical device that received FDA 510(k) clearance on 2020-08-21. It is manufactured by Scivita Medical Technology Co., Ltd.. The 510(k) number is K200216.

When was 4K UHD Camera System approved by the FDA?

4K UHD Camera System received FDA 510(k) clearance on 2020-08-21, under approval number K200216.

What company makes 4K UHD Camera System?

4K UHD Camera System is manufactured by Scivita Medical Technology Co., Ltd..

What is the FDA product code for 4K UHD Camera System?

The FDA product code for 4K UHD Camera System is HET.

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Other Devices by Scivita Medical Technology Co., Ltd.

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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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