Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013546957

FEI Number

3013546957

Entity Name

Cerner Corporation

City/State/Country

Kansas City, MO, US

Establishment Address

8779 Hillcrest Rd, Kansas City, MO 64138, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Cerner Corporation (Owner Number: 9011113)

Owner / Operator Contact Address

8779 Hillcrest Road, --, Kansas City, MO 64138, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K151672

PMA Number

N/A

All Registered Proprietary Names

Oracle Health Patient Observer Cerner CareAware IBus Oracle Health Blood Bank Cerner FetaLink+ Oracle Health Transfusion Administration and Oracle Health Bridge Specimen Collection Image Viewer Oracle Health Event Management

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2016-01-12
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2009-12-11
MMH	Blood Establishment Computer Software And Accessories	Hematology	Class 2	864.9165	2006-11-01
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2012-11-05
MMH	Blood Establishment Computer Software And Accessories	Hematology	Class 2	864.9165	2007-11-13
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2006-11-01
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2016-02-24

Official Correspondent

Eri Gremi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cerner Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008058132	Oracle Cerner Healthcare Solutions India Private Limited	Bangalore Karnataka, IN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K131913	Philips Medizin Systeme Boeblingen GmbH	INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC	2013-11-26
K771196	Hewlett-Packard Co.	MARKER GENERATOR MODULES - 21597A	1977-08-03
K813458	Cranbury Medical Labs, Inc.	FETASCAN 1000, 1000A OBSTETRICAL DATA	1982-01-28
K100420	Philips Medizin Systeme Boeblingen GmbH	PHILIPS OBTRACEVUE MODEL SW REV. G.00	2010-07-26
K173941	Philips Medizin Systeme Boeblingen GmbH	IntelliSpace Perinatal Rev.K.00	2018-09-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-06	N/A	2	FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)
Z-0036-06	N/A	2	FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013546957. Last updated year: 2026. Please use registration number 3013546957 when referencing this establishment in official correspondence.