IPASS BOLUS TRACKING

System, Nuclear Magnetic Resonance Imaging

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 Ipass Bolus Tracking.

Pre-market Notification Details

Device IDK992412
510k NumberK992412
Device Name:IPASS BOLUS TRACKING
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland,  OH  44143
ContactElaine K Keeler
CorrespondentElaine K Keeler
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland,  OH  44143
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-20
Decision Date1999-08-17
Summary:summary

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