Vyntus/SentrySuite Product Line— 510(k) K183567

Substantially Equivalent

Vyaire Medical

FDA 510(k) clearance K183567 for Vyntus/SentrySuite Product Line, Substantially Equivalent on 2019-08-23. Applicant: Vyaire Medical. Device class: 2.

Clearance details

Applicant: Vyaire Medical
Product code: Code BZC
Device class: Class 2
Regulation: 21 CFR 868.1880
Advisory panel: Anesthesiology
Date received: 2018-12-21
Decision date: 2019-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoechber, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.