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The FDA's 510(k) clearance of medical devices is based on proven substantial equivalence with claimed predicate device(s). In concert with the.

Jeffreys eberhardNational electrical manufacturers associationPerformance based pathway devicePerformance criteriaPerformance based pathwaySubmission shouldRefuse to acceptPre market notificationDevice user fee cover sheetReview submission cover sheetMouse statementDisclosure statementElectrical manufacturers associationSignal to noise ratioDiagnostic magnetic resonanceImage uniformity