SIEMENS CARDIOSTAT 701

Electrocardiograph

ELMED, INC.

The following data is part of a premarket notification filed by Elmed, Inc. with the FDA for Siemens Cardiostat 701.

Pre-market Notification Details

Device IDK790794
510k NumberK790794
Device Name:SIEMENS CARDIOSTAT 701
ClassificationElectrocardiograph
Applicant ELMED, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-04-24
Decision Date1979-05-31

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