Primary Relief
K-Number: K213188 · 2022-01-31
ApplicantDyansys, Inc.
Decision Date2022-01-31
Product CodeNHI
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Primary Relief is a medical device manufactured by Dyansys, Inc.. It received FDA 510(k) clearance on 2022-01-31 under approval number K213188. 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 Primary Relief?
Primary Relief is a medical device that received FDA 510(k) clearance on 2022-01-31. It is manufactured by Dyansys, Inc.. The 510(k) number is K213188.
When was Primary Relief approved by the FDA?
Primary Relief received FDA 510(k) clearance on 2022-01-31, under approval number K213188.
What company makes Primary Relief?
Primary Relief is manufactured by Dyansys, Inc..
What is the FDA product code for Primary Relief?
The FDA product code for Primary Relief is NHI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.