FDA 510(k)

Aco Apache Ultrasound System

K-Number: K231509 · 2023-10-24

Decision Date2023-10-24

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Aco Apache Ultrasound System is a medical device manufactured by Aco Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2023-10-24 under approval number K231509. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aco Apache Ultrasound System?

Aco Apache Ultrasound System is a medical device that received FDA 510(k) clearance on 2023-10-24. It is manufactured by Aco Healthcare Co., Ltd.. The 510(k) number is K231509.

When was Aco Apache Ultrasound System approved by the FDA?

Aco Apache Ultrasound System received FDA 510(k) clearance on 2023-10-24, under approval number K231509.

What company makes Aco Apache Ultrasound System?

Aco Apache Ultrasound System is manufactured by Aco Healthcare Co., Ltd..

What is the FDA product code for Aco Apache Ultrasound System?

The FDA product code for Aco Apache Ultrasound System is IYN.

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Other Devices by Aco Healthcare Co., Ltd.

K211232Apache Ultrasound System

Related Devices (Code: IYN)

K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi , Ltd. K163138Clarius Ultrasound SystemClarius Mobile Health Corp. K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics K162583ALOKA LISENDO 880Hitachi , Ltd. K163020Xperius Ultrasound SystemPhilips Health Care

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.