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FDA 510(k)

CoverScan v1

K-Number: K212565 · 2022-05-19

Decision Date2022-05-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CoverScan v1 is a medical device manufactured by Perspectum, Ltd.. It received FDA 510(k) clearance on 2022-05-19 under approval number K212565. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CoverScan v1?

CoverScan v1 is a medical device that received FDA 510(k) clearance on 2022-05-19. It is manufactured by Perspectum, Ltd.. The 510(k) number is K212565.

When was CoverScan v1 approved by the FDA?

CoverScan v1 received FDA 510(k) clearance on 2022-05-19, under approval number K212565.

What company makes CoverScan v1?

CoverScan v1 is manufactured by Perspectum, Ltd..

What is the FDA product code for CoverScan v1?

The FDA product code for CoverScan v1 is LLZ.

Other Devices by Perspectum, Ltd.

Related Devices (Code: LLZ)

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.