K Number
K000380

Validate with FDA (Live)

Device Name
FOTOMASTER
Date Cleared
2000-05-03

(86 days)

Product Code
Regulation Number
892.2050
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

Loading...

N/A