|
gptkbp:instanceOf
|
gptkb:regulatory_process
|
|
gptkbp:administeredBy
|
gptkb:U.S._Food_and_Drug_Administration
|
|
gptkbp:alternativeTo
|
Premarket Approval (PMA)
|
|
gptkbp:application
|
gptkb:medical_device_manufacturer
gptkb:distributor
importer
|
|
gptkbp:appliesTo
|
medical devices
|
|
gptkbp:compatibleWith
|
Class III medical devices
|
|
gptkbp:contrastsWith
|
predicate device
|
|
gptkbp:country
|
gptkb:United_States
|
|
gptkbp:database
|
FDA 510(k) Premarket Notification Database
|
|
gptkbp:demonstrates
|
substantial equivalence
|
|
gptkbp:introducedIn
|
1976
|
|
gptkbp:legalBasis
|
Section 510(k) of the Food, Drug, and Cosmetic Act
|
|
gptkbp:notOutcome
|
approval
|
|
gptkbp:purpose
|
premarket notification
|
|
gptkbp:relatedTo
|
gptkb:medical_device
PMA
De Novo classification
|
|
gptkbp:requires
|
Class II medical devices
Class I medical devices
marketing medical devices in the United States
|
|
gptkbp:result
|
clearance
|
|
gptkbp:reviewedBy
|
gptkb:FDA_Center_for_Devices_and_Radiological_Health
|
|
gptkbp:submissionIncludes
|
labeling
performance data
device description
intended use
substantial equivalence comparison
|
|
gptkbp:YouTubeChannel
|
premarket submission
|
|
gptkbp:bfsParent
|
gptkb:AMRA_Medical
gptkb:AMRA
|
|
gptkbp:bfsLayer
|
8
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
FDA 510(k)
|