ERGO SRS

System, Planning, Radiation Therapy Treatment

3D LINE USA, INC.

The following data is part of a premarket notification filed by 3d Line Usa, Inc. with the FDA for Ergo Srs.

Pre-market Notification Details

Device IDK031281
510k NumberK031281
Device Name:ERGO SRS
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant 3D LINE USA, INC. 11419 CROWNRIDGE RD., STE.15 Owings Mills,  MD  21117
ContactNader Salehi
CorrespondentNader Salehi
3D LINE USA, INC. 11419 CROWNRIDGE RD., STE.15 Owings Mills,  MD  21117
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-04-22
Decision Date2003-12-23
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.