Any instrument, apparatus, appliance, material, or other article, whether used alone or in combination (including the software necessary for its proper application), intended by the manufacturer to be used for human beings for the purpose of:
- Diagnosing, preventing, monitoring, treating, or alleviating disease.
- Diagnosing, preventing, monitoring, treating, alleviating, or compensating for an injury or handicap.
- Investigating, replacing, or modifying of the anatomy or of a physiological process.
Note: This term also encompasses medical device sets.
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