ECSCOPE 100

Electrocardiograph

DYANSYS, INC.

The following data is part of a premarket notification filed by Dyansys, Inc. with the FDA for Ecscope 100.

Pre-market Notification Details

Device IDK091358
510k NumberK091358
Device Name:ECSCOPE 100
ClassificationElectrocardiograph
Applicant DYANSYS, INC. 577 AIRPORT BLVD. Burlingame,  CA  95032
ContactSrini Nageshwar
CorrespondentNed Divine
UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook,  IL  60062
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-05-08
Decision Date2009-05-28
Summary:summary

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