KGT Posted August 19, 2009 Share Posted August 19, 2009 I have a question that maybe someone can point me in the right direction. If a company acquires a 510k cleared software devices and they want to change the name of the original software to reflect the new company's name is there a regulation that describes this process or any forms that need to be completed and submitted?Thank You. Link to comment Share on other sites More sharing options...
L106 Posted August 19, 2009 Share Posted August 19, 2009 I don't understand. Are you with an institution that purchased the software for your use, or are you with a software or instrumentation company that now owns the 510k-cleared software devices (which you plan to market to others?) Link to comment Share on other sites More sharing options...
KGT Posted August 20, 2009 Author Share Posted August 20, 2009 We are a software company that has acquired a 510k-cleared software device that we do plan to market to others. Link to comment Share on other sites More sharing options...
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