PHILIPS TOMOSCAN AV EXPANDER UPGRADE

System, X-ray, Tomography, Computed

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 Philips Tomoscan Av Expander Upgrade.

Pre-market Notification Details

Device IDK964318
510k NumberK964318
Device Name:PHILIPS TOMOSCAN AV EXPANDER UPGRADE
ClassificationSystem, X-ray, Tomography, Computed
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton,  CT  06484
ContactPeter Altman
CorrespondentPeter Altman
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton,  CT  06484
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-29
Decision Date1997-01-10
Summary:summary

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