FDA 510(k)

Apache Ultrasound System (Model C62)

K-Number: K202074 · 2020-11-12

Decision Date2020-11-12

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Apache Ultrasound System (Model C62) is the device name listed in this FDA 510(k) record. The listed applicant is Compal Electronics, Inc.. It received FDA 510(k) clearance on 2020-11-12 under 510(k) number K202074. 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 Apache Ultrasound System (Model C62)?

Apache Ultrasound System (Model C62) is a medical device that received FDA 510(k) clearance on 2020-11-12. The listed applicant is Compal Electronics, Inc.. The 510(k) number is K202074.

When did Apache Ultrasound System (Model C62) receive FDA 510(k) clearance?

Apache Ultrasound System (Model C62) received FDA 510(k) clearance on 2020-11-12, under 510(k) number K202074.

Who is the listed applicant for Apache Ultrasound System (Model C62)?

The FDA 510(k) record lists Compal Electronics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Apache Ultrasound System (Model C62)?

The FDA product code for Apache Ultrasound System (Model C62) is IYN.

Other records listing Compal Electronics, Inc. as applicant

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Official Source

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