MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX— 510(k) K120577

Name: FDA 510(k) clearance K120577
Creator: U.S. Food and Drug Administration
Published: 2015-06-24

Substantially Equivalent

Medikro OY

FDA 510(k) clearance K120577 for MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX, Substantially Equivalent on 2015-06-24. Applicant: Medikro OY. Device class: 2.

Clearance details

Applicant: Medikro OY
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2012-02-27
Decision date: 2015-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kuopio, FI

Download summary PDF View on FDA.gov ↗

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