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 the device name listed in this FDA 510(k) record. The listed applicant is Aco Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2023-10-24 under 510(k) 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. The listed applicant is Aco Healthcare Co., Ltd.. The 510(k) number is K231509.

When did Aco Apache Ultrasound System receive FDA 510(k) clearance?

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

Who is the listed applicant for Aco Apache Ultrasound System?

The FDA 510(k) record lists Aco Healthcare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Aco Healthcare Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211232Apache Ultrasound System

Related Devices (Code: IYN)

Official Source

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