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K Number
K071730
Device Name
STUDIODOP VICORDER
Manufacturer
SKIDMORE MEDICAL, LIMITED
Date Cleared
2007-12-20

(178 days)

Product Code
JOP
Regulation Number
870.2880
Type
Abbreviated
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.2880 Ultrasonic transducer.

(a)
Identification. An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.(b)
Classification. Class II (performance standards).