Statements (34)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory process
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:alternativeTo |
Premarket Approval (PMA)
|
| gptkbp:application |
importer
distributor medical device manufacturer |
| 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
|
| https://www.w3.org/2000/01/rdf-schema#label |
FDA 510(k)
|
| gptkbp:introducedIn |
1976
|
| gptkbp:legalBasis |
Section 510(k) of the Food, Drug, and Cosmetic Act
|
| gptkbp:notOutcome |
approval
|
| gptkbp:purpose |
premarket notification
|
| gptkbp:relatedTo |
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
|