SONIVATE MEDICAL, INC.

Address:4640 S Macadam Ave Ste 200,Portland,OR,97239,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Imaging, Pulsed Echo, Ultrasonic (IYO) (2) Transducer, Ultrasonic, Diagnostic (ITX) (2)

Premarket Exempt

Clear

SonicEye® Dual-Array Ultrasound System - 00850012978008 Catalog Number :

Device Description : Lightweight, battery-powered ultrasound system with dual-array fingertip transdu Lightweight, battery-powered ultrasound system with dual-array fingertip transducer. Transducer incorporated a high-frequency liner array and a low-frequency phased array.

Device Class : 2

Duns Number: 135945496

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : Yes

Device Count : 1

GUI - 00850012978015 Catalog Number :