GENESIS ECP

Device, Counter-pulsating, External

SCOTTCARE CORPORATION

The following data is part of a premarket notification filed by Scottcare Corporation with the FDA for Genesis Ecp.

Pre-market Notification Details

Device IDK081359
510k NumberK081359
Device Name:GENESIS ECP
ClassificationDevice, Counter-pulsating, External
Applicant SCOTTCARE CORPORATION 4791 WEST 150TH ST. Cleveland,  OH  44135
ContactRonald J Clines
CorrespondentRonald J Clines
SCOTTCARE CORPORATION 4791 WEST 150TH ST. Cleveland,  OH  44135
Product CodeDRN  
CFR Regulation Number870.5225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-05-15
Decision Date2008-05-29
Summary:summary

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