RALCO, MODEL R225 ACS— 510(k) K091517

Substantially Equivalent

Ralco S.R.L.

FDA 510(k) clearance K091517 for RALCO, MODEL R225 ACS, Substantially Equivalent on 2009-07-14. Applicant: Ralco S.R.L.. Device class: 2.

Clearance details

Applicant: Ralco S.R.L.
Product code: Code IZW
Device class: Class 2
Regulation: 21 CFR 892.1610
Advisory panel: Radiology
Date received: 2009-05-22
Decision date: 2009-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deerfield, IL, US

Download summary PDF View on FDA.gov ↗

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