NEWTOM 5G / NEWTOM 5G VERSION FP— 510(k) K110260

Substantially Equivalent

Qr S.R.L.

FDA 510(k) clearance K110260 for NEWTOM 5G / NEWTOM 5G VERSION FP, Substantially Equivalent on 2011-04-06. Applicant: Qr S.R.L.. Device class: 2.

Clearance details

Applicant: Qr S.R.L.
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2011-01-28
Decision date: 2011-04-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Verona, IT

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.