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FDA 510(k)

Vyntus/SentrySuite Product Line

K-Number: K183567 · 2019-08-23

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

Device Summary

Vyntus/SentrySuite Product Line is the device name listed in this FDA 510(k) record. The listed applicant is Vyaire Medical. It received FDA 510(k) clearance on 2019-08-23 under 510(k) 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. The listed applicant is Vyaire Medical. The 510(k) number is K183567.

When did Vyntus/SentrySuite Product Line receive FDA 510(k) clearance?

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

Who is the listed applicant for Vyntus/SentrySuite Product Line?

The FDA 510(k) record lists Vyaire Medical as the applicant. This does not by itself establish the device manufacturer.

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

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

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Related Devices (Code: BZC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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