P20 Series Digital Color Doppler Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

Sonoscape Medical Corp.

The following data is part of a premarket notification filed by Sonoscape Medical Corp. with the FDA for P20 Series Digital Color Doppler Ultrasound System.

Pre-market Notification Details

Device IDK172993
510k NumberK172993
Device Name:P20 Series Digital Color Doppler Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Sonoscape Medical Corp. 4/f, 5/f, 8/f, 9/f & 10/f yizhe Building, Yuquan Road, Nanshan Shenzhen,  CN 518051
ContactToki Wu
CorrespondentToki Wu
Sonoscape Medical Corp. 4/f, 5/f, 8/f, 9/f & 10/f yizhe Building, Yuquan Road, Nanshan Shenzhen,  CN 518051
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-27
Decision Date2017-12-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06945868612078 K172993 000
06945868612061 K172993 000
06945868612054 K172993 000
06945868612047 K172993 000
06945868612030 K172993 000
06945868612023 K172993 000
06945868602680 K172993 000
06945868602673 K172993 000
06945868602666 K172993 000

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