FDA 510(k)

Sentry WEB SmartInterp

K-Number: K153654 · 2016-09-16

Decision Date2016-09-16

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Sentry WEB SmartInterp is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion Germany 234 GmbH. It received FDA 510(k) clearance on 2016-09-16 under 510(k) number K153654. 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 Sentry WEB SmartInterp?

Sentry WEB SmartInterp is a medical device that received FDA 510(k) clearance on 2016-09-16. The listed applicant is Carefusion Germany 234 GmbH. The 510(k) number is K153654.

When did Sentry WEB SmartInterp receive FDA 510(k) clearance?

Sentry WEB SmartInterp received FDA 510(k) clearance on 2016-09-16, under 510(k) number K153654.

Who is the listed applicant for Sentry WEB SmartInterp?

The FDA 510(k) record lists Carefusion Germany 234 GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sentry WEB SmartInterp?

The FDA product code for Sentry WEB SmartInterp is DQK.

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 Medical K252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC K253463ILR 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

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