FDA.reportPublic FDA data

Sonivate Medical, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30095650603009565060Sonivate Medical, Inc.1N2026-01-014640 S Macadam Ave Ste 200 Portland OR US 97239

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850012978008SonicEye® Dual-Array Ultrasound System - Lightweight, battery-powered ultrasound system with dual-array fingertip transducer. Transducer incorporated a high-frequency liner array and a low-frequency phased array.301-498-4100inquire@sonivate.com
00850012978008SonicEye® Dual-Array Ultrasound System - Lightweight, battery-powered ultrasound system with dual-array fingertip transducer. Transducer incorporated a high-frequency liner array and a low-frequency phased array.971-220-7871inquire@sonivate.com
00850012978015GUI - Lightweight, battery-powered ultrasound system with dual-array fingertip transducer. Transducer incorporated a high-frequency liner array and a low-frequency phased array.971-220-7871inquire@sonivate.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1406741140601056K192253SonicEye Dual-Array Ultrasound SystemIYO2020-02-25
1406741663158661K113832SONICEYE ULTRASOUND TRANSDUCERITX2012-03-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYO12020-02-25
ITX12012-03-06

GUDID#