Search Results
Found 2 results
510(k) Data Aggregation
Manufacturer
Date Cleared
2000-03-21
(33 days)
Product Code
Regulation Number
886.5925Type
TraditionalPanel
OphthalmicAge 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
Ask a Question
Ask a specific question about this device
Device Name
LIFESTYLE BREAK THRU (POLYMACON)Manufacturer
Date Cleared
1997-03-11
(85 days)
Product Code
Regulation Number
886.5925Type
TraditionalPanel
OphthalmicAge 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
Ask a Question
Ask a specific question about this device
Page 1 of 1