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FDA 510(k)

21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5)

K-Number: K131137 · 2013-07-18

ApplicantJvckenwood Corporation
Decision Date2013-07-18
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5) is the device name listed in this FDA 510(k) record. The listed applicant is Jvckenwood Corporation. It received FDA 510(k) clearance on 2013-07-18 under 510(k) number K131137. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5)?

21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5) is a medical device that received FDA 510(k) clearance on 2013-07-18. The listed applicant is Jvckenwood Corporation. The 510(k) number is K131137.

When did 21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5) receive FDA 510(k) clearance?

21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5) received FDA 510(k) clearance on 2013-07-18, under 510(k) number K131137.

Who is the listed applicant for 21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5)?

The FDA 510(k) record lists Jvckenwood Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5)?

The FDA product code for 21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5) is LLZ.

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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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