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FDA 510(k)

DT-100

K-Number: K160358 · 2017-02-24

Decision Date2017-02-24
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DT-100 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 2017-02-24 under 510(k) number K160358. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DT-100?

DT-100 is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is Mediana Co., Ltd.. The 510(k) number is K160358.

When did DT-100 receive FDA 510(k) clearance?

DT-100 received FDA 510(k) clearance on 2017-02-24, under 510(k) number K160358.

Who is the listed applicant for DT-100?

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 DT-100?

The FDA product code for DT-100 is FLL.

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.

Related Devices (Code: FLL)

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.

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.