Extract to table

The name must be the actual corporate name, and the place of business must include the street address, city, state, and zip code

If the device is not manufactured by the person whose name appears on the label, the label must qualify the name with a phrase such as "Manufactured for," "Distributed by," or "Manufactured by [name], Distributed by [name]

Required label statements must appear on the principal display panel or, if permitted, on the information panel

) The device label must include the name and place of business information sufficient to allow the FDA and consumers to contact the responsible entity

" Additionally, the device must bear labeling that provides adequate information for the prescribing practitioner to use the device safely and for its intended purpose

Software-related labeling claims—including claims regarding algorithm performance, trend arrow generation, and predictive alert features—must be consistent with the software documentation provided in the 510(k) submission