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)

ZeeroMED View

K-Number: K200546 · 2020-05-05

ApplicantO3 Enterprise Srl
Decision Date2020-05-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ZeeroMED View is a medical device manufactured by O3 Enterprise Srl. It received FDA 510(k) clearance on 2020-05-05 under approval number K200546. 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 ZeeroMED View?

ZeeroMED View is a medical device that received FDA 510(k) clearance on 2020-05-05. It is manufactured by O3 Enterprise Srl. The 510(k) number is K200546.

When was ZeeroMED View approved by the FDA?

ZeeroMED View received FDA 510(k) clearance on 2020-05-05, under approval number K200546.

What company makes ZeeroMED View?

ZeeroMED View is manufactured by O3 Enterprise Srl.

What is the FDA product code for ZeeroMED View?

The FDA product code for ZeeroMED View is LLZ.

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.

↑