HEPCON HMS WITH BODY SURFACE AREA CALCULATION

Analyzer, Heparin, Automated

HEMOTECH, INC.

The following data is part of a premarket notification filed by Hemotech, Inc. with the FDA for Hepcon Hms With Body Surface Area Calculation.

Pre-market Notification Details

Device IDK911240
510k NumberK911240
Device Name:HEPCON HMS WITH BODY SURFACE AREA CALCULATION
ClassificationAnalyzer, Heparin, Automated
Applicant HEMOTECH, INC. 7103 S. REVERE PKWY. Englewood,  CO  80112
ContactRobert F Baugh
CorrespondentRobert F Baugh
HEMOTECH, INC. 7103 S. REVERE PKWY. Englewood,  CO  80112
Product CodeJOX  
CFR Regulation Number864.5680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-21
Decision Date1991-07-17

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