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FDA 510(k)

Cyware 4H and Cysart 4H

K-Number: K221796 · 2022-12-30

ApplicantAbys Medical
Decision Date2022-12-30
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Cyware 4H and Cysart 4H is a medical device manufactured by Abys Medical. It received FDA 510(k) clearance on 2022-12-30 under approval number K221796. 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 Cyware 4H and Cysart 4H?

Cyware 4H and Cysart 4H is a medical device that received FDA 510(k) clearance on 2022-12-30. It is manufactured by Abys Medical. The 510(k) number is K221796.

When was Cyware 4H and Cysart 4H approved by the FDA?

Cyware 4H and Cysart 4H received FDA 510(k) clearance on 2022-12-30, under approval number K221796.

What company makes Cyware 4H and Cysart 4H?

Cyware 4H and Cysart 4H is manufactured by Abys Medical.

What is the FDA product code for Cyware 4H and Cysart 4H?

The FDA product code for Cyware 4H and Cysart 4H is LLZ.

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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.

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