FDA 510(k)

FM20

K-Number: K110612 · 2011-11-08

Decision Date2011-11-08

Product CodeHGM

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

FM20 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 2011-11-08 under 510(k) number K110612. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FM20?

FM20 is a medical device that received FDA 510(k) clearance on 2011-11-08. The listed applicant is Mediana Co., Ltd.. The 510(k) number is K110612.

When did FM20 receive FDA 510(k) clearance?

FM20 received FDA 510(k) clearance on 2011-11-08, under 510(k) number K110612.

Who is the listed applicant for FM20?

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 FM20?

The FDA product code for FM20 is HGM.

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 SNF K170497V10 K160358DT-100 K152659V10 K112190PATIENT MONITOR K110630F10

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.