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FDA 510(k)

Medisystem Pacs

K-Number: K223048 · 2023-06-23

Decision Date2023-06-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Medisystem Pacs is a medical device manufactured by Medilab Manutencao E Sitemas Ltda. It received FDA 510(k) clearance on 2023-06-23 under approval number K223048. 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 Medisystem Pacs?

Medisystem Pacs is a medical device that received FDA 510(k) clearance on 2023-06-23. It is manufactured by Medilab Manutencao E Sitemas Ltda. The 510(k) number is K223048.

When was Medisystem Pacs approved by the FDA?

Medisystem Pacs received FDA 510(k) clearance on 2023-06-23, under approval number K223048.

What company makes Medisystem Pacs?

Medisystem Pacs is manufactured by Medilab Manutencao E Sitemas Ltda.

What is the FDA product code for Medisystem Pacs?

The FDA product code for Medisystem Pacs is LLZ.

Related Devices (Code: LLZ)

Official Source

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