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FDA 510(k)

LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30

K-Number: K100217 · 2010-06-08

ApplicantMediana Co., Ltd.
Decision Date2010-06-08
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30 is the device name listed in this FDA 510(k) record. The listed applicant is Mediana Co., Ltd.. It received FDA 510(k) clearance on 2010-06-08 under 510(k) number K100217. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30?

LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30 is a medical device that received FDA 510(k) clearance on 2010-06-08. The listed applicant is Mediana Co., Ltd.. The 510(k) number is K100217.

When did LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30 receive FDA 510(k) clearance?

LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30 received FDA 510(k) clearance on 2010-06-08, under 510(k) number K100217.

Who is the listed applicant for LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30?

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

What is the FDA product code for LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30?

The FDA product code for LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30 is MHX.

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Other records listing Mediana 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.

K200434V20, V20a, AVSM3 SNFK170497V10K160358DT-100K152659V10K112190PATIENT MONITORK110612FM20

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Related Devices (Code: MHX)

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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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