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FDA 510(k)

5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2)

K-Number: K061447 · 2006-07-21

ApplicantTotoku Electric Co., Ltd.
Decision Date2006-07-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2) is the device name listed in this FDA 510(k) record. The listed applicant is Totoku Electric Co., Ltd.. It received FDA 510(k) clearance on 2006-07-21 under 510(k) number K061447. 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 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2)?

5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2) is a medical device that received FDA 510(k) clearance on 2006-07-21. The listed applicant is Totoku Electric Co., Ltd.. The 510(k) number is K061447.

When did 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2) receive FDA 510(k) clearance?

5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2) received FDA 510(k) clearance on 2006-07-21, under 510(k) number K061447.

Who is the listed applicant for 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2)?

The FDA 510(k) record lists Totoku Electric Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2)?

The FDA product code for 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2) 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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