NUMED BALLOON THERMODILUTION CATHETER

Probe, Thermodilution

NUMED, INC.

The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Numed Balloon Thermodilution Catheter.

Pre-market Notification Details

Device IDK881893
510k NumberK881893
Device Name:NUMED BALLOON THERMODILUTION CATHETER
ClassificationProbe, Thermodilution
Applicant NUMED, INC. MAIN ST. Hopkinton,  NY  12940
ContactAllen J Tower
CorrespondentAllen J Tower
NUMED, INC. MAIN ST. Hopkinton,  NY  12940
Product CodeKRB  
CFR Regulation Number870.1915 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-05-05
Decision Date1988-09-06

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