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FDA 510(k)

EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE

K-Number: K081873 · 2008-07-16

ApplicantShenzhen Emperor Electronic Technology Co. , Ltd.
Decision Date2008-07-16
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Emperor Electronic Technology Co. , Ltd.. It received FDA 510(k) clearance on 2008-07-16 under 510(k) number K081873. 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 EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE?

EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE is a medical device that received FDA 510(k) clearance on 2008-07-16. The listed applicant is Shenzhen Emperor Electronic Technology Co. , Ltd.. The 510(k) number is K081873.

When did EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE receive FDA 510(k) clearance?

EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE received FDA 510(k) clearance on 2008-07-16, under 510(k) number K081873.

Who is the listed applicant for EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE?

The FDA 510(k) record lists Shenzhen Emperor Electronic Technology Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE?

The FDA product code for EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE is IYO.

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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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