PHILIPS DUO DIAGNOST

Interventional Fluoroscopic X-ray System

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 Duo Diagnost.

Pre-market Notification Details

Device IDK983069
510k NumberK983069
Device Name:PHILIPS DUO DIAGNOST
ClassificationInterventional Fluoroscopic X-ray System
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 CodeOWB  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-02
Decision Date1998-11-02
Summary:summary

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