CARDIO 7

Electrocardiograph

BIONET CO., LTD.

The following data is part of a premarket notification filed by Bionet Co., Ltd. with the FDA for Cardio 7.

Pre-market Notification Details

Device IDK113306
510k NumberK113306
Device Name:CARDIO 7
ClassificationElectrocardiograph
Applicant BIONET CO., LTD. 5405 ALTON PARKWAY, SUITE A530 Irvine,  CA  92604
ContactMarc Goodman
CorrespondentMarc Goodman
BIONET CO., LTD. 5405 ALTON PARKWAY, SUITE A530 Irvine,  CA  92604
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-11-09
Decision Date2012-07-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
18809276943559 K113306 000

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