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Dear all:
We produce blood pressure monitor, and it has get the K number, now we want to change its MCU, so we will do the design modification verification on the new device, and i know that maybe it don't need to submit a new 510(k), according to the guidance document < Deciding when to submit new 510(k) for a change to the existing device>. However, at the same time, we don't want to discard the old design specification. Because the customer may ask for the device with the old MCU, do we have to submit a new 510(k) for the device with a new MCU?
We produce blood pressure monitor, and it has get the K number, now we want to change its MCU, so we will do the design modification verification on the new device, and i know that maybe it don't need to submit a new 510(k), according to the guidance document < Deciding when to submit new 510(k) for a change to the existing device>. However, at the same time, we don't want to discard the old design specification. Because the customer may ask for the device with the old MCU, do we have to submit a new 510(k) for the device with a new MCU?