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FDA 510(k)

RTapp

K-Number: K212887 · 2021-11-10

ApplicantSegana, Inc.
Decision Date2021-11-10
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RTapp is a medical device manufactured by Segana, Inc.. It received FDA 510(k) clearance on 2021-11-10 under approval number K212887. 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 2021-11-10. It is manufactured by Segana, Inc.. The 510(k) number is K212887.

When was RTapp approved by the FDA?

RTapp received FDA 510(k) clearance on 2021-11-10, under approval number K212887.

What company makes RTapp?

RTapp is manufactured by Segana, Inc..

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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