BREATHID HP SYSTEM— 510(k) K130524

Substantially Equivalent

Exalenz Bioscience , Ltd.

FDA 510(k) clearance K130524 for BREATHID HP SYSTEM, Substantially Equivalent on 2013-05-22. Applicant: Exalenz Bioscience , Ltd.. Device class: 1.

Clearance details

Applicant: Exalenz Bioscience , Ltd.
Product code: Code MSQ
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 2013-02-28
Decision date: 2013-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheat Ridge, CO, 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.