QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER

Flowmeter, Blood, Cardiovascular

NEOPROBE CORP.

The following data is part of a premarket notification filed by Neoprobe Corp. with the FDA for Quantix/or Blood Flow Monitor; Flexible Probe With Optional Vessel Stabilizer.

Pre-market Notification Details

Device IDK050088
510k NumberK050088
Device Name:QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER
ClassificationFlowmeter, Blood, Cardiovascular
Applicant NEOPROBE CORP. 425 METRO PLACE NORTH, STE. 300 Dublin,  OH  43017
ContactRodger A Brown
CorrespondentRodger A Brown
NEOPROBE CORP. 425 METRO PLACE NORTH, STE. 300 Dublin,  OH  43017
Product CodeDPW  
CFR Regulation Number870.2100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-01-13
Decision Date2005-02-08
Summary:summary

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