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FDA 510(k)

Parcus Synd-EZ SS

K-Number: K192964 · 2019-11-22

Decision Date2019-11-22
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Parcus Synd-EZ SS is a medical device manufactured by Parcus Medical, LLC. It received FDA 510(k) clearance on 2019-11-22 under approval number K192964. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Parcus Synd-EZ SS?

Parcus Synd-EZ SS is a medical device that received FDA 510(k) clearance on 2019-11-22. It is manufactured by Parcus Medical, LLC. The 510(k) number is K192964.

When was Parcus Synd-EZ SS approved by the FDA?

Parcus Synd-EZ SS received FDA 510(k) clearance on 2019-11-22, under approval number K192964.

What company makes Parcus Synd-EZ SS?

Parcus Synd-EZ SS is manufactured by Parcus Medical, LLC.

What is the FDA product code for Parcus Synd-EZ SS?

The FDA product code for Parcus Synd-EZ SS is MBI.

Other Devices by Parcus Medical, LLC

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Related Devices (Code: MBI)

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.