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FDA 510(k)

Apache Ultrasound System (Model C62)

K-Number: K202074 · 2020-11-12

ApplicantCompal Electronics, Inc.
Decision Date2020-11-12
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Apache Ultrasound System (Model C62) is a medical device manufactured by Compal Electronics, Inc.. It received FDA 510(k) clearance on 2020-11-12 under approval 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. It is manufactured by Compal Electronics, Inc.. The 510(k) number is K202074.

When was Apache Ultrasound System (Model C62) approved by the FDA?

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

What company makes Apache Ultrasound System (Model C62)?

Apache Ultrasound System (Model C62) is manufactured by Compal Electronics, Inc..

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

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

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Related Devices (Code: IYN)

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Official Source

View on FDA Database →

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

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