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Device RegistrationThe U.S. Food and Drug Administration classifies defibrillators as a medical device that requires tracking (knowing where the device is). As such, federal regulations require that manufacturers maintain tracking information for each device distributed. We rely on our customers to provide accurate device location information. This tracking information provides the manufacturer the ability to locate the device and perform a product correction, should it ever be needed. Tracking information must specify the physical location of the device, not just the headquarters or receiving department’s shipping address. The tracking information required is:
Step 1 of 2: Your Contact Information |
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