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FDA 510(k)

MREplus+ Software

K-Number: K183193 · 2019-08-01

ApplicantResoundant, Inc.
Decision Date2019-08-01
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MREplus+ Software is a medical device manufactured by Resoundant, Inc.. It received FDA 510(k) clearance on 2019-08-01 under approval number K183193. 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 MREplus+ Software?

MREplus+ Software is a medical device that received FDA 510(k) clearance on 2019-08-01. It is manufactured by Resoundant, Inc.. The 510(k) number is K183193.

When was MREplus+ Software approved by the FDA?

MREplus+ Software received FDA 510(k) clearance on 2019-08-01, under approval number K183193.

What company makes MREplus+ Software?

MREplus+ Software is manufactured by Resoundant, Inc..

What is the FDA product code for MREplus+ Software?

The FDA product code for MREplus+ Software is LLZ.

Other Devices by Resoundant, Inc.

K201389Resoundant Acoustic Driver System

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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.

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