FDA 510(k)

DM-Density

K-Number: K170540 · 2018-02-23

Decision Date2018-02-23

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DM-Density is the device name listed in this FDA 510(k) record. The listed applicant is Densitas, Inc.. It received FDA 510(k) clearance on 2018-02-23 under 510(k) number K170540. 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 DM-Density?

DM-Density is a medical device that received FDA 510(k) clearance on 2018-02-23. The listed applicant is Densitas, Inc.. The 510(k) number is K170540.

When did DM-Density receive FDA 510(k) clearance?

DM-Density received FDA 510(k) clearance on 2018-02-23, under 510(k) number K170540.

Who is the listed applicant for DM-Density?

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

What is the FDA product code for DM-Density?

The FDA product code for DM-Density is LLZ.

Other records listing Densitas, Inc. 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.

K192973densitas densityai

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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.