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.

Clearance details

Applicant: Aerocrine AB
Product code: Code MXA
Advisory panel: Clinical Toxicology
Date received: 2010-04-14
Decision date: 2010-09-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Solna, SE

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