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FDA 510(k)

SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM

K-Number: K152881 · 2016-04-01

ApplicantSpacelabs Healthcare, Ltd.
Decision Date2016-04-01
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM is a medical device manufactured by Spacelabs Healthcare, Ltd.. It received FDA 510(k) clearance on 2016-04-01 under approval number K152881. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM?

SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2016-04-01. It is manufactured by Spacelabs Healthcare, Ltd.. The 510(k) number is K152881.

When was SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM approved by the FDA?

SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM received FDA 510(k) clearance on 2016-04-01, under approval number K152881.

What company makes SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM?

SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM is manufactured by Spacelabs Healthcare, Ltd..

What is the FDA product code for SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM?

The FDA product code for SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM is DQK.

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Related PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025) PMID: 32459382 Safety Assessment of an A-Scan Ultrasonic System for Ophthalmic Use. Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine (2020) PMID: 31472187 A translational framework for peripheral nerve stimulating electrodes: Reviewing the journey from concept to clinic. Journal of neuroscience methods (2019) PMID: 25262248 Unique device identifiers for coronary stent postmarket surveillance and research: a report from the Food and Drug Administration Medical Device Epidemiology Network Unique Device Identifier demonstration. American heart journal (2014)

Other Devices by Spacelabs Healthcare, Ltd.

K211651Eclipse PRO K201921Spacelabs Lifescreen PRO Analyzer K212317Eclipse MINI Model 98900

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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