Can I read Brivo XR385 510(k) Summary on EtoBox?

Brivo XR385 510(k) Summary by rafik is a document available to read on EtoBox.

What is Brivo XR385 510(k) Summary about?

The document is a 510(k) summary for the Brivo XR385 Digital Diagnostic Radiographic System submitted to the FDA. It provides information on the submitter, device description, intended use, comparison to predicate devices, and conclusion that the Brivo XR385 is substantially equivalent to other legally marketed devices through non-clinical testing. The FDA issued a letter finding the Brivo XR385 substantially equivalent for the stated indications for use.

Author

rafik

Language

EN