Diagnostic Ultrasound System

System, Imaging, Pulsed Echo, Ultrasonic

Edan Instruments, Inc.

The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK192791
510k NumberK192791
Device Name:Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen,  CN 518122
ContactStella Guo
CorrespondentStella Guo
Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen,  CN 518122
Product CodeIYO  
Subsequent Product CodeITX
Subsequent Product CodeIYN
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-30
Decision Date2019-11-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06944413812703 K192791 000
06944413811461 K192791 000
06944413811478 K192791 000
06944413811485 K192791 000
06944413811492 K192791 000
06944413811508 K192791 000
06944413811522 K192791 000
06944413811546 K192791 000
06944413811560 K192791 000
06944413811584 K192791 000
06944413811744 K192791 000
06944413811751 K192791 000
06944413812185 K192791 000
06944413811454 K192791 000

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