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FDA 510(k)

i-Rapha Solution

K-Number: K201296 · 2020-07-09

ApplicantIrm, Inc.
Decision Date2020-07-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

i-Rapha Solution is a medical device manufactured by Irm, Inc.. It received FDA 510(k) clearance on 2020-07-09 under approval number K201296. 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 i-Rapha Solution?

i-Rapha Solution is a medical device that received FDA 510(k) clearance on 2020-07-09. It is manufactured by Irm, Inc.. The 510(k) number is K201296.

When was i-Rapha Solution approved by the FDA?

i-Rapha Solution received FDA 510(k) clearance on 2020-07-09, under approval number K201296.

What company makes i-Rapha Solution?

i-Rapha Solution is manufactured by Irm, Inc..

What is the FDA product code for i-Rapha Solution?

The FDA product code for i-Rapha Solution is LLZ.

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Official Source

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