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FDA 510(k)

CERNER CAREAWARE IBUS

K-Number: K093134 · 2009-11-27

ApplicantCerner Corp.
Decision Date2009-11-27
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CERNER CAREAWARE IBUS is the device name listed in this FDA 510(k) record. The listed applicant is Cerner Corp.. It received FDA 510(k) clearance on 2009-11-27 under 510(k) number K093134. 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 CERNER CAREAWARE IBUS?

CERNER CAREAWARE IBUS is a medical device that received FDA 510(k) clearance on 2009-11-27. The listed applicant is Cerner Corp.. The 510(k) number is K093134.

When did CERNER CAREAWARE IBUS receive FDA 510(k) clearance?

CERNER CAREAWARE IBUS received FDA 510(k) clearance on 2009-11-27, under 510(k) number K093134.

Who is the listed applicant for CERNER CAREAWARE IBUS?

The FDA 510(k) record lists Cerner Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CERNER CAREAWARE IBUS?

The FDA product code for CERNER CAREAWARE IBUS is DRG.

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Other records listing Cerner Corp. 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.

K121758CERNER FETALINK+(VERSION1.0)K091251CERNER FETALINK (VERSION 1.0)K091032CERNER PROVISION WORKSTATION (VERSION 2.5)K070394CERNER PROVISION WORKSTATIONK000770PROVIEW MEDICAL IMAGE DISPLAY MODULEK955000REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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