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FDA 510(k)

RTapp

K-Number: K191610 · 2019-10-01

ApplicantSegana, LLC
Decision Date2019-10-01
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RTapp is a medical device manufactured by Segana, LLC. It received FDA 510(k) clearance on 2019-10-01 under approval number K191610. 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 RTapp?

RTapp is a medical device that received FDA 510(k) clearance on 2019-10-01. It is manufactured by Segana, LLC. The 510(k) number is K191610.

When was RTapp approved by the FDA?

RTapp received FDA 510(k) clearance on 2019-10-01, under approval number K191610.

What company makes RTapp?

RTapp is manufactured by Segana, LLC.

What is the FDA product code for RTapp?

The FDA product code for RTapp is LLZ.

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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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