FDA · official record K110260Substantially Equivalent

NEWTOM 5G / NEWTOM 5G VERSION FP

Name: NEWTOM 5G / NEWTOM 5G VERSION FP — FDA K110260
Creator: Qr S.R.L.
Keywords: NEWTOM 5G / NEWTOM 5G VERSION FP, NEWTOM 5G / NEWTOM 5G VERSION FP, K110260, OAS, FDA

United StatesOASQr S.R.L.

Verified

Official record identity

FDA application number: K110260
Decision date: April 06, 2011
Published decision: Substantially Equivalent

Classification

Product code: OAS

Published parties

Applicant: Qr S.R.L.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2011-01-28
Review panel: Radiology
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 892.1750

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.