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FDA 510(k)

DIGITAL ULTRASOUND SCANNER

K-Number: K100079 · 2010-03-01

ApplicantShenzhen Well.D Medical Electronics Co., Ltd.
Decision Date2010-03-01
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL ULTRASOUND SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Well.D Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2010-03-01 under 510(k) number K100079. 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 DIGITAL ULTRASOUND SCANNER?

DIGITAL ULTRASOUND SCANNER is a medical device that received FDA 510(k) clearance on 2010-03-01. The listed applicant is Shenzhen Well.D Medical Electronics Co., Ltd.. The 510(k) number is K100079.

When did DIGITAL ULTRASOUND SCANNER receive FDA 510(k) clearance?

DIGITAL ULTRASOUND SCANNER received FDA 510(k) clearance on 2010-03-01, under 510(k) number K100079.

Who is the listed applicant for DIGITAL ULTRASOUND SCANNER?

The FDA 510(k) record lists Shenzhen Well.D Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGITAL ULTRASOUND SCANNER?

The FDA product code for DIGITAL ULTRASOUND SCANNER 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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