Fenom Pro Nitric Oxide Test— 510(k) K182874

Substantially Equivalent

Spirosure, Inc.

FDA 510(k) clearance K182874 for Fenom Pro Nitric Oxide Test, Substantially Equivalent on 2019-02-13. Applicant: Spirosure, Inc..

Clearance details

Applicant: Spirosure, Inc.
Product code: Code MXA
Advisory panel: Clinical Toxicology
Date received: 2018-10-12
Decision date: 2019-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

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