NIOX MINO MODEL 09-1000— 510(k) K101034

Substantially Equivalent

Aerocrine AB

FDA 510(k) clearance K101034 for NIOX MINO MODEL 09-1000, Substantially Equivalent on 2010-09-02. Applicant: Aerocrine AB. Device class: 2.

Clearance details

Applicant: Aerocrine AB
Product code: Code MXA
Device class: Class 2
Regulation: 21 CFR 862.3080
Advisory panel: Clinical Toxicology
Date received: 2010-04-14
Decision date: 2010-09-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Solna, SE

Download summary PDF View on FDA.gov ↗

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DEN030001 — NIOX ARTICLE NO: 02-10002003-04-30

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