NIOX MINO— 510(k) K072816

Substantially Equivalent

Aerocrine AB

FDA 510(k) clearance K072816 for NIOX MINO, Substantially Equivalent on 2008-03-03. Applicant: Aerocrine AB.

Clearance details

Applicant: Aerocrine AB
Product code: Code MXA
Advisory panel: Clinical Toxicology
Date received: 2007-10-02
Decision date: 2008-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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