SOMATOM P30 CT SYSTEMS

System, X-ray, Tomography, Computed

SIEMENS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Siemens Medical Systems, Inc. with the FDA for Somatom P30 Ct Systems.

Pre-market Notification Details

Device IDK013522
510k NumberK013522
Device Name:SOMATOM P30 CT SYSTEMS
ClassificationSystem, X-ray, Tomography, Computed
Applicant SIEMENS MEDICAL SYSTEMS, INC. 186 WOOD AVENUE SOUTH Iselin,  NJ  08830
ContactPraveen Nadkarni
CorrespondentWolfram Gmelin
TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton,  CT  06470
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2001-10-23
Decision Date2001-11-07
Summary:summary

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