NS-HGlio— 510(k) K221738

Substantially Equivalent

Neosoma, Inc.

FDA 510(k) clearance K221738 for NS-HGlio, Substantially Equivalent on 2022-09-27. Applicant: Neosoma, Inc.. Device class: 2.

Clearance details

Applicant: Neosoma, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2022-06-15
Decision date: 2022-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Groton, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.