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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 the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs Healthcare, Ltd.. It received FDA 510(k) clearance on 2016-04-01 under 510(k) 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. The listed applicant is Spacelabs Healthcare, Ltd.. The 510(k) number is K152881.

When did SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM receive FDA 510(k) clearance?

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

Who is the listed applicant for SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM?

The FDA 510(k) record lists Spacelabs Healthcare, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Spacelabs Healthcare, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

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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