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FDA 510(k)

First Relief

K-Number: K212859 · 2021-12-20

ApplicantDyansys, Inc.
Decision Date2021-12-20
Product CodeNHI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

First Relief is a medical device manufactured by Dyansys, Inc.. It received FDA 510(k) clearance on 2021-12-20 under approval number K212859. The device is classified under product code NHI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the First Relief?

First Relief is a medical device that received FDA 510(k) clearance on 2021-12-20. It is manufactured by Dyansys, Inc.. The 510(k) number is K212859.

When was First Relief approved by the FDA?

First Relief received FDA 510(k) clearance on 2021-12-20, under approval number K212859.

What company makes First Relief?

First Relief is manufactured by Dyansys, Inc..

What is the FDA product code for First Relief?

The FDA product code for First Relief is NHI.

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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.