ST-Z5— 510(k) K201878

Substantially Equivalent

Z-Systems AG

FDA 510(k) clearance K201878 for ST-Z5, Substantially Equivalent on 2021-03-25. Applicant: Z-Systems AG. Device class: 2.

Clearance details

Applicant: Z-Systems AG
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2020-07-07
Decision date: 2021-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oensingen, CH

Download summary PDF View on FDA.gov ↗

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