|
gptkb:510(k)_premarket_notification_for_medical_devices
|
proposed indications for use
|
|
gptkb:510(k)_premarket_notification_for_medical_devices
|
labeling
|
|
gptkb:Section_510(k)_(Premarket_Notification)
|
intended use
|
|
gptkb:510(k)_premarket_notification_for_medical_devices
|
performance data
|
|
gptkb:510(k)_clearance_in_US
|
proposed indications for use
|
|
gptkb:510(k)_premarket_notification_for_medical_devices
|
intended use
|
|
gptkb:510(k)_premarket_notification_for_medical_devices
|
device description
|
|
gptkb:510(k)_premarket_notification_for_medical_devices
|
substantial equivalence comparison
|
|
gptkb:FDA_510(k)
|
substantial equivalence comparison
|
|
gptkb:FDA_510(k)
|
intended use
|
|
gptkb:Premarket_Approval_(PMA)_for_medical_devices
|
clinical studies
|
|
gptkb:Premarket_Approval_(PMA)_for_medical_devices
|
labeling
|
|
gptkb:FDA_510(k)
|
labeling
|
|
gptkb:Premarket_Approval_(PMA)_for_medical_devices
|
preclinical studies
|
|
gptkb:510(k)_clearance_in_US
|
device description
|
|
gptkb:Section_510(k)_(Premarket_Notification)
|
safety and effectiveness information
|
|
gptkb:510(k)_clearance_in_US
|
predicate device information
|
|
gptkb:FDA_510(k)
|
device description
|
|
gptkb:FDA_510(k)
|
performance data
|
|
gptkb:Premarket_Approval_(PMA)_for_medical_devices
|
manufacturing information
|