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We have a medical device (system) that is composed of 6 distinct entities (hardware and software). These entities are such that they could be sold separately or together as an entire system.
We are contemplating if there are would be any benefit in filing separate 510(k) for each entity or just one for the entire system. In the 510(k) it would be possible to state that these entities could be combine or sold separately.
Has anyone experienced any specific benefits by intentionally submitting separate 510(K) per sub-system?
Thanks,
Rishi.
We are contemplating if there are would be any benefit in filing separate 510(k) for each entity or just one for the entire system. In the 510(k) it would be possible to state that these entities could be combine or sold separately.
Has anyone experienced any specific benefits by intentionally submitting separate 510(K) per sub-system?
Thanks,
Rishi.