CLINIX MP

Interventional Fluoroscopic X-ray System

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 Clinix Mp.

Pre-market Notification Details

Device IDK960920
510k NumberK960920
Device Name:CLINIX MP
ClassificationInterventional Fluoroscopic X-ray System
Applicant PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Highland Heights,  OH  44143
ContactRobert L Turocy
CorrespondentRobert L Turocy
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Highland Heights,  OH  44143
Product CodeOWB  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-03-06
Decision Date1996-05-20
Summary:summary

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