P12 Elite 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 P12 Elite Series Digital Color Doppler Ultrasound System.

Pre-market Notification Details

Device IDK221089
510k NumberK221089
Device Name:P12 Elite Series Digital Color Doppler Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Sonoscape Medical Corp. Room 201&202, 12th Building, Shenzhen Software Park Phase II 1 Keji Middle 2nd Road, Yuehai Subdistrict, Nanshan Shenzhen,  CN 518057
ContactToki Wu
CorrespondentToki Wu
Sonoscape Medical Corp. Room 201&202, 12th Building, Shenzhen Software Park Phase II 1 Keji Middle 2nd Road, Yuehai Subdistrict, Nanshan Shenzhen,  CN 518057
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-13
Decision Date2022-09-15

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