MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO— 510(k) K133428

Name: FDA 510(k) clearance K133428
Creator: U.S. Food and Drug Administration
Published: 2014-05-21

Substantially Equivalent

Medikro OY

FDA 510(k) clearance K133428 for MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO, Substantially Equivalent on 2014-05-21. 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: 2013-11-08
Decision date: 2014-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kuopio, FI

Download summary PDF View on FDA.gov ↗

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