Vyntus / SentrySuite Product Line— 510(k) K150810

Clearance details

Applicant

Carefusion Germany 234 GmbH

Product code

Code BZC

Device class

Class 2

Regulation

21 CFR 868.1880

Advisory panel

Anesthesiology

Date received

2015-03-26

Decision date

2015-08-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hoechberg, DE

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• Z-1730-2024 — Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connected to the adapter for DVT. Twin Tube Probenschlauch (707004), which is sold outside the US only. Used in breath analysis for metabolic response study.Class I·Ongoing·Vyaire Medical, Inc.·20240408

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150810.