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FDA 510(k)

HealthOST

K-Number: K213944 · 2022-04-22

ApplicantNanoxai , Ltd.
Decision Date2022-04-22
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HealthOST is a medical device manufactured by Nanoxai , Ltd.. It received FDA 510(k) clearance on 2022-04-22 under approval number K213944. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HealthOST?

HealthOST is a medical device that received FDA 510(k) clearance on 2022-04-22. It is manufactured by Nanoxai , Ltd.. The 510(k) number is K213944.

When was HealthOST approved by the FDA?

HealthOST received FDA 510(k) clearance on 2022-04-22, under approval number K213944.

What company makes HealthOST?

HealthOST is manufactured by Nanoxai , Ltd..

What is the FDA product code for HealthOST?

The FDA product code for HealthOST is JAK.

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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.

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