Cleared Traditional

Vyntus/SentrySuite Product Line

K183567 · Vyaire Medical · Anesthesiology

Aug 2019

Decision

245d

Days

Class 2

Risk

About This 510(k) Submission

K183567 is an FDA 510(k) clearance for the Vyntus/SentrySuite Product Line, a Calculator, Pulmonary Function Data (Class II — Special Controls, product code BZC), submitted by Vyaire Medical (Hoechber, DE). The FDA issued a Cleared decision on August 23, 2019, 245 days after receiving the submission on December 21, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1880.

Submission Details

510(k) Number	K183567 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 2018
Decision Date	August 23, 2019
Days to Decision	245 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF