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Oracle Cerner Healthcare Solutions India Private Limited: FDA-registered device maker in Bangalore Karnataka, India, 1 510(k) clearance

Oracle Cerner Healthcare Solutions India Private Limited is registered with the FDA (registration 3008058132) in Bangalore Karnataka, India. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 27, 2009. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

FDA registration number
3008058132
Address
Level 3 Block H2 Mountain Ash Manyata Embassy Business (Sez) Outer Ring Road(Hebbal-KR Puram Section) Nagawara, Bangalore Karnataka, India, 560045
Owner or operator
Cerner Corporation (9011113)
Roles
Manufacturer
First device listed
November 1, 2006
Registered through
2026
Brand names listed
Cerner CareAware IBus, Oracle Health Blood Bank, Oracle Health Transfusion Administration and Oracle Health Bridge Specimen Collection

Devices it lists

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 27, 2009K093134CERNER CAREAWARE IBUSDRGSubstantially EquivalentCerner Corp.accessdata.fda.gov

Compare with other makers

Updated November 27, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.