BEACON, MODEL 211060

System, Tomography, Computed, Emission

PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.

The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Beacon, Model 211060.

Pre-market Notification Details

Device IDK983948
510k NumberK983948
Device Name:BEACON, MODEL 211060
ClassificationSystem, Tomography, Computed, Emission
Applicant PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Highland Heights,  OH  44143
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-05
Decision Date1999-04-16
Summary:summary

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