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FDA 510(k)

DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System

K-Number: K183660 · 2019-04-09

ApplicantShenzhen Mindray Bio-Medical Electronics Co., Ltd.
Decision Date2019-04-09
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-04-09 under 510(k) number K183660. 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 DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System?

DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System is a medical device that received FDA 510(k) clearance on 2019-04-09. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K183660.

When did DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System receive FDA 510(k) clearance?

DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System received FDA 510(k) clearance on 2019-04-09, under 510(k) number K183660.

Who is the listed applicant for DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System?

The FDA 510(k) record lists Shenzhen Mindray Bio-Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System?

The FDA product code for DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System is IYN.

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Related Devices (Code: IYN)

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.

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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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