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FDA 510(k)

DC-7 DIAGNOSTIC ULTRASOUND SYSTEM

K-Number: K101041 · 2010-04-30

ApplicantShenzhen Mindray Bio-Medical Electronics Co., Ltd.
Decision Date2010-04-30
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DC-7 DIAGNOSTIC ULTRASOUND 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 2010-04-30 under 510(k) number K101041. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DC-7 DIAGNOSTIC ULTRASOUND SYSTEM?

DC-7 DIAGNOSTIC ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2010-04-30. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K101041.

When did DC-7 DIAGNOSTIC ULTRASOUND SYSTEM receive FDA 510(k) clearance?

DC-7 DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance on 2010-04-30, under 510(k) number K101041.

Who is the listed applicant for DC-7 DIAGNOSTIC ULTRASOUND 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 DC-7 DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA product code for DC-7 DIAGNOSTIC ULTRASOUND SYSTEM is ITX.

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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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