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FDA 510(k)

AVIEW Modeler

K-Number: K192040 · 2019-12-20

Decision Date2019-12-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AVIEW Modeler is a medical device manufactured by Coreline Soft Co., Ltd.. It received FDA 510(k) clearance on 2019-12-20 under approval number K192040. 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 AVIEW Modeler?

AVIEW Modeler is a medical device that received FDA 510(k) clearance on 2019-12-20. It is manufactured by Coreline Soft Co., Ltd.. The 510(k) number is K192040.

When was AVIEW Modeler approved by the FDA?

AVIEW Modeler received FDA 510(k) clearance on 2019-12-20, under approval number K192040.

What company makes AVIEW Modeler?

AVIEW Modeler is manufactured by Coreline Soft Co., Ltd..

What is the FDA product code for AVIEW Modeler?

The FDA product code for AVIEW Modeler is LLZ.

Other Devices by Coreline Soft Co., Ltd.

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Related Devices (Code: LLZ)

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.