FDA 510(k)

HealthOST

K-Number: K213944 · 2022-04-22

Decision Date2022-04-22

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

HealthOST is the device name listed in this FDA 510(k) record. The listed applicant is Nanoxai , Ltd.. It received FDA 510(k) clearance on 2022-04-22 under 510(k) 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. The listed applicant is Nanoxai , Ltd.. The 510(k) number is K213944.

When did HealthOST receive FDA 510(k) clearance?

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

Who is the listed applicant for HealthOST?

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

What is the FDA product code for HealthOST?

The FDA product code for HealthOST is JAK.

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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.