Apache Ultrasound System (Model C62)

FDA 510(k) K202074 · Compal Electronics, Inc.

Substantially Equivalent

510(k) numberK202074

Submission

Device name
Apache Ultrasound System (Model C62)
Applicant
Compal Electronics, Inc.
Taipei, TW
Received
July 27, 2020
Decision date
November 12, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYN – System, Imaging, Pulsed Doppler, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1550
Specialty
Radiology

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Questions and answers

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

Apache Ultrasound System (Model C62) (K202074) received a 510(k) decision of Substantially Equivalent on November 12, 2020, 108 days after the submission was received.

What is the product code of K202074?

The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.