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Hi all:
We are designing an apps which can measure some body signal such as the blood pressure, and i know we have to submit 510(k) because it is an accessory/part of the medical device. If we decide to measure other type of body signal by such apps, for example the body weight, and we all know that a device only measure the body weight which does claim any medical puepose will not be considered to be a medical device. Does such kind of design modification trigger a new 510(k)?
Any input will be appreciated.
We are designing an apps which can measure some body signal such as the blood pressure, and i know we have to submit 510(k) because it is an accessory/part of the medical device. If we decide to measure other type of body signal by such apps, for example the body weight, and we all know that a device only measure the body weight which does claim any medical puepose will not be considered to be a medical device. Does such kind of design modification trigger a new 510(k)?
Any input will be appreciated.
