K Number
K010640Manufacturer
Date Cleared
2001-03-20
(15 days)
Product Code
Regulation Number
870.2060Type
SpecialPanel
CVReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 870.2060 Transducer signal amplifier and conditioner.
(a)
Identification. A transducer signal amplifier and conditioner is a device used to provide the excitation energy for the transducer and to amplify or condition the signal emitted by the transducer.(b)
Classification. Class II (performance standards).