FOLEY CATHETERS WITH TEMPERATURE PROBE

Catheter, Upper Urinary Tract

GE HEALTHCARE

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Foley Catheters With Temperature Probe.

Pre-market Notification Details

Device IDK061918
510k NumberK061918
Device Name:FOLEY CATHETERS WITH TEMPERATURE PROBE
ClassificationCatheter, Upper Urinary Tract
Applicant GE HEALTHCARE 86 PILGRIM ROAD Needham,  MA  02492
ContactJoel Kent
CorrespondentJoel Kent
GE HEALTHCARE 86 PILGRIM ROAD Needham,  MA  02492
Product CodeEYC  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-06
Decision Date2006-08-18
Summary:summary

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