FDA 510(k)

RTapp

K-Number: K212887 · 2021-11-10

Decision Date2021-11-10

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

RTapp is the device name listed in this FDA 510(k) record. The listed applicant is Segana, Inc.. It received FDA 510(k) clearance on 2021-11-10 under 510(k) 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. The listed applicant is Segana, Inc.. The 510(k) number is K212887.

When did RTapp receive FDA 510(k) clearance?

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

Who is the listed applicant for RTapp?

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

What is the FDA product code for RTapp?

The FDA product code for RTapp is LLZ.

Other records listing Segana, Inc. as applicant

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.

K191610RTapp

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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.