FDA 510(k)

NS-HGlio

K-Number: K221738 · 2022-09-27

Decision Date2022-09-27

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

NS-HGlio is the device name listed in this FDA 510(k) record. The listed applicant is Neosoma, Inc.. It received FDA 510(k) clearance on 2022-09-27 under 510(k) number K221738. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NS-HGlio?

NS-HGlio is a medical device that received FDA 510(k) clearance on 2022-09-27. The listed applicant is Neosoma, Inc.. The 510(k) number is K221738.

When did NS-HGlio receive FDA 510(k) clearance?

NS-HGlio received FDA 510(k) clearance on 2022-09-27, under 510(k) number K221738.

Who is the listed applicant for NS-HGlio?

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

What is the FDA product code for NS-HGlio?

The FDA product code for NS-HGlio is QIH.

Other records listing Neosoma, 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.

K252922Neosoma Brain Mets

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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.