PHILIPS ORTHOPAEDIC APPLICATIONS

System, Image Processing, Radiological

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 Orthopaedic Applications.

Pre-market Notification Details

Device IDK042867
510k NumberK042867
Device Name:PHILIPS ORTHOPAEDIC APPLICATIONS
ClassificationSystem, Image Processing, Radiological
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 22100 BOTHELL EVERETT HIGHWAY Bothell,  WA  98021 -8431
ContactLynn T Harmer
CorrespondentMelissa J Deguia
UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook,  IL  60062
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2004-10-18
Decision Date2004-11-02
Summary:summary

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