FDA 510(k)

DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

K-Number: K052113 · 2005-08-09

ApplicantShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Decision Date2005-08-09

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DP-6600 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 2005-08-09 under 510(k) number K052113. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM?

DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2005-08-09. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K052113.

When did DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM receive FDA 510(k) clearance?

DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM received FDA 510(k) clearance on 2005-08-09, under 510(k) number K052113.

Who is the listed applicant for DP-6600 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-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM?

The FDA product code for DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM is IYO.

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Official Source

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