SENSILASE PAD 3000

Flowmeter, Blood, Cardiovascular

OPTICAL SENSORS, INC.

The following data is part of a premarket notification filed by Optical Sensors, Inc. with the FDA for Sensilase Pad 3000.

Pre-market Notification Details

Device IDK040654
510k NumberK040654
Device Name:SENSILASE PAD 3000
ClassificationFlowmeter, Blood, Cardiovascular
Applicant OPTICAL SENSORS, INC. 800 LENANGER LN. Stoughton,  WI  53589
ContactGary Syring
CorrespondentGary Syring
OPTICAL SENSORS, INC. 800 LENANGER LN. Stoughton,  WI  53589
Product CodeDPW  
CFR Regulation Number870.2100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-12
Decision Date2004-06-04
Summary:summary

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