FDA 510(k)

INTEL-GE CARE INNOVATIONS QUIETCARE

K-Number: K131585 · 2013-10-08

Decision Date2013-10-08

Product CodeKMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

INTEL-GE CARE INNOVATIONS QUIETCARE 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 2013-10-08 under 510(k) number K131585. The device is classified under product code KMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEL-GE CARE INNOVATIONS QUIETCARE?

INTEL-GE CARE INNOVATIONS QUIETCARE is a medical device that received FDA 510(k) clearance on 2013-10-08. The listed applicant is Intel-Ge Care Innovations, LLC. The 510(k) number is K131585.

When did INTEL-GE CARE INNOVATIONS QUIETCARE receive FDA 510(k) clearance?

INTEL-GE CARE INNOVATIONS QUIETCARE received FDA 510(k) clearance on 2013-10-08, under 510(k) number K131585.

Who is the listed applicant for INTEL-GE CARE INNOVATIONS QUIETCARE?

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 INTEL-GE CARE INNOVATIONS QUIETCARE?

The FDA product code for INTEL-GE CARE INNOVATIONS QUIETCARE is KMI.

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Other records listing Intel-Ge Care Innovations, LLC as applicant

K130821INTEL-GE CARE INNOVATIONS CONNECT RCM K130290MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE

Related Devices (Code: KMI)

K130752DYNASENSE SYSTEMCentauri Medical, Inc.K101109VIVATRAKWireless Medcare, LLC K090138MOBILECARE MONITOR, MODEL 2100Aframe Digital, Inc.K942770ULTIMAT-SENSOR FOR BED OCCUPANCY MONITORUltimate Development Corp.K943481INFORMER PLUSMicro-Tech Medical, Inc.K933552PM-PAGERHill Engineering

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.