Cleared Traditional

Vyntus / SentrySuite Product Line

K150810 · Carefusion Germany 234 GmbH · Anesthesiology
Aug 2015
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K150810 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 Carefusion Germany 234 GmbH (Hoechberg, DE). The FDA issued a Cleared decision on August 14, 2015, 141 days after receiving the submission on March 26, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1880.

Submission Details

510(k) Number K150810 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2015
Decision Date August 14, 2015
Days to Decision 141 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZC — Calculator, Pulmonary Function Data
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1880

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