Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

densitas densityai

K-Number: K192973 · 2020-02-19

ApplicantDensitas, Inc.
Decision Date2020-02-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

densitas densityai is a medical device manufactured by Densitas, Inc.. It received FDA 510(k) clearance on 2020-02-19 under approval number K192973. 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 densitas densityai?

densitas densityai is a medical device that received FDA 510(k) clearance on 2020-02-19. It is manufactured by Densitas, Inc.. The 510(k) number is K192973.

When was densitas densityai approved by the FDA?

densitas densityai received FDA 510(k) clearance on 2020-02-19, under approval number K192973.

What company makes densitas densityai?

densitas densityai is manufactured by Densitas, Inc..

What is the FDA product code for densitas densityai?

The FDA product code for densitas densityai is LLZ.

Other Devices by Densitas, Inc.

K170540DM-Density

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

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.

↑