AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER

Device, Blood Volume Measuring

DAXOR CORPORATION

The following data is part of a premarket notification filed by Daxor Corporation with the FDA for Automated Multi-point Blood Volume Analyzer.

Pre-market Notification Details

Device IDK964406
510k NumberK964406
Device Name:AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER
ClassificationDevice, Blood Volume Measuring
Applicant DAXOR CORPORATION 350 FIFTH AVE., SUITE 7120 New York,  NY  10118
ContactJoseph Feldschuh
CorrespondentJoseph Feldschuh
DAXOR CORPORATION 350 FIFTH AVE., SUITE 7120 New York,  NY  10118
Product CodeJWO  
CFR Regulation Number864.5950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-04
Decision Date1997-09-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B641BVA100SOFTWARE60 K964406 000

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