MULTIDIAGNOST ELEVA

System, X-ray, Stationary

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 Multidiagnost Eleva.

Pre-market Notification Details

Device IDK050151
510k NumberK050151
Device Name:MULTIDIAGNOST ELEVA
ClassificationSystem, X-ray, Stationary
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 22100 BOTHELL EVERETT HWY P.O. BOX 3003 Bothell,  WA  98021 -8431
ContactLynn Harmer
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2005-01-24
Decision Date2005-02-09
Summary:summary

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