THERMODILUTION KIT

Probe, Thermodilution

AMERICAN PHARMASEAL DIV. AHSC

The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Thermodilution Kit.

Pre-market Notification Details

Device IDK811480
510k NumberK811480
Device Name:THERMODILUTION KIT
ClassificationProbe, Thermodilution
Applicant AMERICAN PHARMASEAL DIV. AHSC 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKRB  
CFR Regulation Number870.1915 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-05-27
Decision Date1981-06-09

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