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FDA 510(k)

Ziostation2

K-Number: K200315 · 2020-05-05

ApplicantZiosoft, Inc.
Decision Date2020-05-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ziostation2 is a medical device manufactured by Ziosoft, Inc.. It received FDA 510(k) clearance on 2020-05-05 under approval number K200315. 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 Ziostation2?

Ziostation2 is a medical device that received FDA 510(k) clearance on 2020-05-05. It is manufactured by Ziosoft, Inc.. The 510(k) number is K200315.

When was Ziostation2 approved by the FDA?

Ziostation2 received FDA 510(k) clearance on 2020-05-05, under approval number K200315.

What company makes Ziostation2?

Ziostation2 is manufactured by Ziosoft, Inc..

What is the FDA product code for Ziostation2?

The FDA product code for Ziostation2 is LLZ.

Other Devices by Ziosoft, Inc.

K181892Ziostation2

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Official Source

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