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FDA 510(k)

MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE

K-Number: K130290 · 2013-06-04

ApplicantIntel-Ge Care Innovations, LLC
Decision Date2013-06-04
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Intel-Ge Care Innovations, LLC. It received FDA 510(k) clearance on 2013-06-04 under 510(k) number K130290. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE?

MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE is a medical device that received FDA 510(k) clearance on 2013-06-04. The listed applicant is Intel-Ge Care Innovations, LLC. The 510(k) number is K130290.

When did MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE receive FDA 510(k) clearance?

MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE received FDA 510(k) clearance on 2013-06-04, under 510(k) number K130290.

Who is the listed applicant for MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE?

The FDA 510(k) record lists Intel-Ge Care Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE?

The FDA product code for MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE is DRG.

Related Clinical Trials

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Other records listing Intel-Ge Care Innovations, LLC 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.

K131585INTEL-GE CARE INNOVATIONS QUIETCAREK130821INTEL-GE CARE INNOVATIONS CONNECT RCM

Related Devices (Code: DRG)

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.

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.

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.

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