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FDA 510(k)

DM-Density

K-Number: K170540 · 2018-02-23

ApplicantDensitas, Inc.
Decision Date2018-02-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DM-Density is a medical device manufactured by Densitas, Inc.. It received FDA 510(k) clearance on 2018-02-23 under approval 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. It is manufactured by Densitas, Inc.. The 510(k) number is K170540.

When was DM-Density approved by the FDA?

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

What company makes DM-Density?

DM-Density is manufactured by Densitas, Inc..

What is the FDA product code for DM-Density?

The FDA product code for DM-Density is LLZ.

Other Devices by Densitas, Inc.

K192973densitas densityai

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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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