Two or more predicates suitable? 510K submission

Shawna

Starting to get Involved
I am wondering whether we can use two or more predicates for our scope prodcut's 510K submission. We have a wireless scope product, of which the image is transferred to display by wifi. So we are planning to use one predicate for the scope hardware, another software predicate for our wireless transfer software, because we can't find single one product as predicate. 1. anyone know whether two or more predicates are appropriate. 2. in 510K database, the entry of 1980's or older doesn't have any summary or statement. The establishment associated seems not to be found. I think maybe the establishment doesn't exist anymore or changed its name or was purchased by other company. In this case, how can we know more information about the product and its establishment? I searched the product in Google but got no luck. I know we can contact FOIA but it takes too long. Thanks for any help
 
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Shawna

Starting to get Involved
I am wondering whether we can use two or more predicates for our scope prodcut's 510K submission. We have a wireless scope product, of which the image is transferred to display by wifi. So we are planning to use one predicate for the scope hardware, another software predicate for our wireless transfer software, because we can't find single one product as predicate. 1. anyone know whether two or more predicates are appropriate. 2. in 510K database, the entry of 1980's or older doesn't have any summary or statement. The establishment associated seems not to be found. I think maybe the establishment doesn't exist anymore or changed its name or was purchased by other company. In this case, how can we know more information about the product and its establishment? I searched the product in Google but got no luck. I know we can contact FOIA but it takes too long. Thanks for any help
 

Shawna

Starting to get Involved
Thank you, Ronen, for bringing the guidance document which is completely out of my mind :D:D.
 
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