HD60 Series Ultrasound Diagnostic System

System, Imaging, Pulsed Doppler, Ultrasonic

Qingdao Hisense Medical Equipment Co., Ltd

The following data is part of a premarket notification filed by Qingdao Hisense Medical Equipment Co., Ltd with the FDA for Hd60 Series Ultrasound Diagnostic System.

Pre-market Notification Details

Device IDK213862
510k NumberK213862
Device Name:HD60 Series Ultrasound Diagnostic System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Qingdao Hisense Medical Equipment Co., Ltd No. 399 Songling Road, Laoshan District Qingdao,  CN 266100
ContactYalan Wu
CorrespondentYalan Wu
Qingdao Hisense Medical Equipment Co., Ltd No. 399 Songling Road, Laoshan District Qingdao,  CN 266100
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-10
Decision Date2022-06-08

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