PF 5050 PRESSURE UNIT, MODEL PF 5050

Flowmeter, Blood, Cardiovascular

PERIMED AB

The following data is part of a premarket notification filed by Perimed Ab with the FDA for Pf 5050 Pressure Unit, Model Pf 5050.

Pre-market Notification Details

Device IDK011899
510k NumberK011899
Device Name:PF 5050 PRESSURE UNIT, MODEL PF 5050
ClassificationFlowmeter, Blood, Cardiovascular
Applicant PERIMED AB DATAVAGEN 9-A Jarfalla,  SE S-175 26
ContactBjorn Bakken
CorrespondentBjorn Bakken
PERIMED AB DATAVAGEN 9-A Jarfalla,  SE S-175 26
Product CodeDPW  
CFR Regulation Number870.2100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-18
Decision Date2001-11-06
Summary:summary

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