Apache Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

Aco Healthcare Co,. Ltd.

The following data is part of a premarket notification filed by Aco Healthcare Co,. Ltd. with the FDA for Apache Ultrasound System.

Pre-market Notification Details

Device IDK211232
510k NumberK211232
Device Name:Apache Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Aco Healthcare Co,. Ltd. Rm. 520, Bldg. 53, No. 195, Sec. 4, Chungshin Rd., Chutung Hsinchu,  TW 31057
ContactHenry Huang
CorrespondentHenry Huang
Aco Healthcare Co,. Ltd. Rm. 520, Bldg. 53, No. 195, Sec. 4, Chungshin Rd., Chutung Hsinchu,  TW 31057
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-23
Decision Date2021-06-25

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