Q13 SPIROLYSER®— 510(k) K161676

Substantially Equivalent

Fim Medical

FDA 510(k) clearance K161676 for Q13 SPIROLYSER®, Substantially Equivalent on 2016-10-20. Applicant: Fim Medical. Device class: 2.

Clearance details

Applicant: Fim Medical
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2016-06-17
Decision date: 2016-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Villeurbanne Cedex , Rhone, FR

Download summary PDF View on FDA.gov ↗

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