FDA 510(k)

Sorin Connect

K-Number: K170460 · 2017-06-08

Decision Date2017-06-08

Product CodeDXJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Sorin Connect is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Deutschland GmbH. It received FDA 510(k) clearance on 2017-06-08 under 510(k) number K170460. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sorin Connect?

Sorin Connect is a medical device that received FDA 510(k) clearance on 2017-06-08. The listed applicant is Sorin Group Deutschland GmbH. The 510(k) number is K170460.

When did Sorin Connect receive FDA 510(k) clearance?

Sorin Connect received FDA 510(k) clearance on 2017-06-08, under 510(k) number K170460.

Who is the listed applicant for Sorin Connect?

The FDA 510(k) record lists Sorin Group Deutschland GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sorin Connect?

The FDA product code for Sorin Connect is DXJ.

Related Devices (Code: DXJ)

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.

K212003ESSENZ Patient MonitorLivanova Deutschland, GmbH K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH K201162Essence 55SP Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd.K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc.K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH K173381Nexxis ORBarco N.V.

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.