PRIMO S— 510(k) K211542

Name: FDA 510(k) clearance K211542
Creator: U.S. Food and Drug Administration
Published: 2021-07-09

Substantially Equivalent

A.T.S. Applicazione Tecnologie Speciali S.R.L.

FDA 510(k) clearance K211542 for PRIMO S, Substantially Equivalent on 2021-07-09. Applicant: A.T.S. Applicazione Tecnologie Speciali S.R.L.. Device class: 2.

Clearance details

Applicant: A.T.S. Applicazione Tecnologie Speciali S.R.L.
Product code: Product code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2021-05-19
Decision date: 2021-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torre De Roveri, IT

Download summary PDF View on FDA.gov ↗

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