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FDA 510(k)

Hepatica v1 (Hepatica v1.0.0)

K-Number: K203280 · 2021-01-12

ApplicantPerspectum, Ltd.
Decision Date2021-01-12
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Hepatica v1 (Hepatica v1.0.0) is the device name listed in this FDA 510(k) record. The listed applicant is Perspectum, Ltd.. It received FDA 510(k) clearance on 2021-01-12 under 510(k) number K203280. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hepatica v1 (Hepatica v1.0.0)?

Hepatica v1 (Hepatica v1.0.0) is a medical device that received FDA 510(k) clearance on 2021-01-12. The listed applicant is Perspectum, Ltd.. The 510(k) number is K203280.

When did Hepatica v1 (Hepatica v1.0.0) receive FDA 510(k) clearance?

Hepatica v1 (Hepatica v1.0.0) received FDA 510(k) clearance on 2021-01-12, under 510(k) number K203280.

Who is the listed applicant for Hepatica v1 (Hepatica v1.0.0)?

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

What is the FDA product code for Hepatica v1 (Hepatica v1.0.0)?

The FDA product code for Hepatica v1 (Hepatica v1.0.0) is LNH.

Other records listing Perspectum, Ltd. 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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