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FDA 510(k)

21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM)

K-Number: K052199 · 2005-09-22

ApplicantTotoku Electric Co., Ltd.
Decision Date2005-09-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM) 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 2005-09-22 under 510(k) number K052199. 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(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM)?

21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM) is a medical device that received FDA 510(k) clearance on 2005-09-22. The listed applicant is Totoku Electric Co., Ltd.. The 510(k) number is K052199.

When did 21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM) receive FDA 510(k) clearance?

21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM) received FDA 510(k) clearance on 2005-09-22, under 510(k) number K052199.

Who is the listed applicant for 21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM)?

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 21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM)?

The FDA product code for 21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM) is LLZ.

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Other records listing Totoku Electric Co., Ltd. as applicant

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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