FDA 510(k)

i-Rapha Solution

K-Number: K201296 · 2020-07-09

Decision Date2020-07-09

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

i-Rapha Solution is the device name listed in this FDA 510(k) record. The listed applicant is Irm, Inc.. It received FDA 510(k) clearance on 2020-07-09 under 510(k) 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. The listed applicant is Irm, Inc.. The 510(k) number is K201296.

When did i-Rapha Solution receive FDA 510(k) clearance?

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

Who is the listed applicant for i-Rapha Solution?

The FDA 510(k) record lists Irm, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.