K Number
K964742Device Name
RONIX II ROTARY ULTRASONIC SURGICAL SYSTEMManufacturer
Date Cleared
1997-04-22
(147 days)
Product Code
Regulation Number
N/AType
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A