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Sterling Medical Devices participated in the development of a Class III CPR assistance system that helps an untrained civilian administer CPR to the patient in critical condition. To address the FDA’s response to a previous 510k submission, the system design includes robust hardware and software that provides positive and negative feedback to the user to ensure the safe and effective use of CPR administration. The update involved a feasibility review and manufacturing assessment of developing the feedback mechanism. We also heavily revised the existing DHF. The device system received 510k approval upon resubmission. Development was performed under Sterling’s QMS then transferred to the client’s QMS.
February 18, 2021