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FDA 510(k)

Vyntus/SentrySuite Product Line

K-Number: K183567 · 2019-08-23

Decision Date2019-08-23
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Vyntus/SentrySuite Product Line is a medical device manufactured by Vyaire Medical. It received FDA 510(k) clearance on 2019-08-23 under approval number K183567. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vyntus/SentrySuite Product Line?

Vyntus/SentrySuite Product Line is a medical device that received FDA 510(k) clearance on 2019-08-23. It is manufactured by Vyaire Medical. The 510(k) number is K183567.

When was Vyntus/SentrySuite Product Line approved by the FDA?

Vyntus/SentrySuite Product Line received FDA 510(k) clearance on 2019-08-23, under approval number K183567.

What company makes Vyntus/SentrySuite Product Line?

Vyntus/SentrySuite Product Line is manufactured by Vyaire Medical.

What is the FDA product code for Vyntus/SentrySuite Product Line?

The FDA product code for Vyntus/SentrySuite Product Line is BZC.

Other Devices by Vyaire Medical

Related Devices (Code: BZC)

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.