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FDA 510(k)

DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic

K-Number: K173471 · 2018-01-08

ApplicantShenzhen Mindray Bio-Medical Electronics Co., Ltd.
Decision Date2018-01-08
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic 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 2018-01-08 under 510(k) number K173471. 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-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic?

DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic is a medical device that received FDA 510(k) clearance on 2018-01-08. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K173471.

When did DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic receive FDA 510(k) clearance?

DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic received FDA 510(k) clearance on 2018-01-08, under 510(k) number K173471.

Who is the listed applicant for DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic?

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-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic?

The FDA product code for DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic 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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