SLS SIMULATOR (MODELS SLS-9 AND SLS-14)

System, Simulation, Radiation Therapy

PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.

The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Sls Simulator (models Sls-9 And Sls-14).

Pre-market Notification Details

Device IDK891293
510k NumberK891293
Device Name:SLS SIMULATOR (MODELS SLS-9 AND SLS-14)
ClassificationSystem, Simulation, Radiation Therapy
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton,  CT  06484
ContactWilliam G Mcmahon
CorrespondentWilliam G Mcmahon
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton,  CT  06484
Product CodeKPQ  
CFR Regulation Number892.5840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-10
Decision Date1989-04-20

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