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FDA 510(k)

CoverScan (CoverScan v1.1)

K-Number: K230294 · 2023-03-03

ApplicantPerspectum
Decision Date2023-03-03
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CoverScan (CoverScan v1.1) is the device name listed in this FDA 510(k) record. The listed applicant is Perspectum. It received FDA 510(k) clearance on 2023-03-03 under 510(k) number K230294. 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 (CoverScan v1.1)?

CoverScan (CoverScan v1.1) is a medical device that received FDA 510(k) clearance on 2023-03-03. The listed applicant is Perspectum. The 510(k) number is K230294.

When did CoverScan (CoverScan v1.1) receive FDA 510(k) clearance?

CoverScan (CoverScan v1.1) received FDA 510(k) clearance on 2023-03-03, under 510(k) number K230294.

Who is the listed applicant for CoverScan (CoverScan v1.1)?

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

What is the FDA product code for CoverScan (CoverScan v1.1)?

The FDA product code for CoverScan (CoverScan v1.1) is LLZ.

Other records listing Perspectum as applicant

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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Related Devices (Code: LLZ)

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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