Cleared Traditional

Sentry WEB SmartInterp

K153654 · Carefusion Germany 234 GmbH · Cardiovascular
Sep 2016
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K153654 is an FDA 510(k) clearance for the Sentry WEB SmartInterp, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Carefusion Germany 234 GmbH (Hoechber, DE). The FDA issued a Cleared decision on September 16, 2016, 270 days after receiving the submission on December 21, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K153654 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2015
Decision Date September 16, 2016
Days to Decision 270 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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