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FDA 510(k)

DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM

K-Number: K083505 · 2008-12-12

ApplicantShenzhen Mindray Bio-Medical Electronics Co., Ltd.
Decision Date2008-12-12
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DC-3/DC-3T 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 2008-12-12 under 510(k) number K083505. 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 DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM?

DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2008-12-12. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K083505.

When did DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM receive FDA 510(k) clearance?

DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance on 2008-12-12, under 510(k) number K083505.

Who is the listed applicant for DC-3/DC-3T 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-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA product code for DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM is 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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