Cleared Traditional

SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM

K152881 · Spacelabs Healthcare, Ltd. · Cardiovascular
Apr 2016
Decision
184d
Days
Class 2
Risk

About This 510(k) Submission

K152881 is an FDA 510(k) clearance for the SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Spacelabs Healthcare, Ltd. (Hertford, GB). The FDA issued a Cleared decision on April 1, 2016, 184 days after receiving the submission on September 30, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K152881 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2015
Decision Date April 01, 2016
Days to Decision 184 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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